Determined Diabetes Educator Uncovers Insulin Pump Supply Issues By Tyler Smith

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1 Volume 4 Issue 20 Through April 26, 2011 Company disputes source of mysterious blood glucose fluctuations Determined Diabetes Educator Uncovers Insulin Pump Supply Issues By Tyler Smith might be traced to the supplies for the insulin pumps they use to help them control the problem. Thanks in large part to Vital s uncommon persistence, willingness to ask questions, and dedication to patient care, Medtronic, the world s largest manufacturer of insulin pumps, agreed to set up a special hot line for UCH patients to report pump-supply problems and to examine its pump supplies for defects. What happened next is in dispute. Tavia Vital, holding pages of instructions for insulin pumps, urges her patients to manage their complex disease closely. That includes checking their pump supplies to ensure they are delivering insulin properly. Tavia Vital knows type 1 diabetes. It s her job. The registered nurse and certified diabetes educator makes her living at University of Colorado Hospital s Endocrine Clinic helping patients understand and manage the complex chronic disease that prevents the body from manufacturing the insulin needed to break down blood sugar. She manages blood glucose levels aggressively. She pays close attention to the array of factors that can raise or lower them, by themselves and in interaction with one another: diet, exercise, stress, weight, and many others. And she teaches her patients to do the same thing because over time, poorly managed diabetes leads to debilitating long-term consequences: heart disease, kidney damage, vision problems, limb damage, even death. Tavia Vital knows type 1 diabetes because she has had type 1 diabetes for 30 years. That simple fact undoubtedly helped her recently to come to a startling and ironic conclusion: the mysterious swings she and some of her patients experienced in their blood glucose levels Vital and a half-dozen colleagues, including other diabetes educators, say members of Medtronic s quality and products teams told them during a March 9 conference call that they had identified pump-supply problems, and had corrected them with changes to their manufacturing lines. The problems, Vital said, included poorly fitting caps for the reservoir that holds the insulin the pump delivers; crookedly placed needles that may not fully pierce the reservoir that connects the insulin from the reservoir to the tubing to the infusion site; and issues with the adhesive used to hold the infusion set the tubing that delivers the insulin to the skin. Each, she said, has the potential to decrease the vital delivery of insulin. Medtronic also asked that patients experiencing severe blood glucose fluctuations or any other problem that they suspected might be related to pump-supply issues to return the items so the company could inspect them. It wasn t a perfect solution, but it was a start, Vital and her colleagues figured. Several issues were left unanswered: how many problem supplies remained in the distribution chain, how long it would take to go through all of them and how Vital and her patients might begin getting the new supplies.

2 Volume 4 Issue 20 Through April 26, 2011 Page 2 Earlier this week, however, a company spokeswoman flatly denied the company or its distributors have found any of the problems Vital described or even that they were discussed during the March conference call (see sidebar, The Company Responds ). And the ability of at least Vital and Vital s patients to monitor and manage their glucose levels with the Medtronic supplies remains in question. Vital stands firmly behind her story, as does UCH Diabetes Educator and Outpatient Diabetes Education Program Coordinator Jenny Madrid, MPH, RD, CDE, BC-ADM, who also attended the meeting. In fact, Vital says, she and some of her patients continue to experience problems that point to insulin leaks. the signals, she began investigating, minutely examining her own behavior for clues to the mystery. Tavia is well-educated about her disease and a problem-solver, Madrid said. She is one of a number of people with type 1 diabetes who are diligent about their care and detail oriented, and they strive to eliminate variables by keeping detailed records, eating the same way every day and getting the same amount of exercise. They are the perfect people to identify a problem because when they see things that don t make sense, they ask questions. Adhesive (white area in center of photo) used to hold the infusion set, must fit tightly to the skin. The cap to the reservoir holding insulin must fit tightly. A thousand variables. But regardless of the outcome of the dispute, even the possibility of problems likely would never have seen the light of day without the intense detective work it takes to understand and address the seemingly random ups and downs of blood glucose levels diabetes patients experience, Madrid said. And the story illustrates how vexingly difficult it is to track down the reasons for fluctuations, even when a patient is using a pump to help modulate insulin delivery (see Pumps a Boon, below). Vital turned her attention to her pump supplies only after she had worked through an exhaustive process of elimination when she observed unexplained swings in her blood sugar. Type 1 diabetes, Madrid notes, is a very complex disease. There are so many variables that affect it. There are so many things that it s hard to pinpoint a specific issue even if there is one. Warning bells went off for Vital when she began to notice unusual spikes in her blood glucose levels last July. Instead of writing off Vital s curiosity heightened when she began hearing reports from some of her patients that they, too, were witnessing unexplained increases in their blood glucose levels. I heard from several people with the same issues, she said. Late last summer, Vital called Medtronic s toll-free 800 number to report the problem and promptly hit a wall. I couldn t get past the script the customer-service people read, she recalled. She said their questions focused on troubleshooting: asking about kinked tubing lines and alarms that signal the pump isn t delivering insulin. I was trying to tell them that I m seeing patients in the clinic with the same problem I have They weren t tracking strangely high blood sugar levels, she said. In November, Vital said, she went to the hospital s Medtronic sales representative to escalate the issue. I said I ve been wearing a pump for nine years and I ve never had this happen. Now it happens one to four times a month, she recalled. Shortly thereafter, a company vice president called her to gather information.

3 Volume 4 Issue 20 Through April 26, 2011 Page 3 He gave it to some company problem-solvers, who first thought I was nuts, Vital said. The problems showed up only intermittently, and the company said it hadn t received similar complaints from other health care facilities. But one day in February, more than six months after she noticed the unusual blood sugar spikes, Vital wrote a series of s to high-ranking quality control officials at Medtronic that described blood glucose levels more than three times higher than normal, even after she checked her pump and infusion sets, ate her regular diet and took a pre-meal bolus of insulin. She described heart palpitations and shortness of breath as well as signs that insulin had leaked from the back of the reservoir that supplies the pump. A rapid increase in blood glucose is cause for immediate concern, Madrid cautioned. When a person doesn t get enough insulin, of course, blood sugar levels rise rapidly. Because the body can t use sugar for fuel, it burns fat and proteins and produces ketones, substances that raise acid levels in the blood. The condition, diabetic ketoacidosis, produces excessive thirst, fatigue, nausea, chest pain, coma or death. Patients may need emergency help to get IV insulin and fluids to reverse the effects, Madrid said. The incident provided a graphic illustration that the problem lay with the equipment, not with the patient, Vital asserted. You can t get high ketone levels without lacking insulin. A Medtronic vice president promised to look into it, and shortly thereafter there were signs the company was taking the issue seriously. It agreed to install a special telephone extension for UCH patients to report sudden blood sugar elevations. Customerservice reps on the hot line were instructed to ask for specific details about the problem, and request that patients send pump supplies back to the company so they could inspect them for quality-control problems and provide replacements. The disputed March conference call followed. Vital and Madrid initially commended Medtronic for their corrective actions, although both said in separate interviews they wish the company had addressed the clinic s concerns more quickly. Once they took it seriously, they worked diligently to figure it out, Madrid said. They have a thousand variables in manufacturing and there is a first for everything in insulin pump therapy. Or so they thought. Both expressed profound disappointment upon hearing that Amanda Sheldon, Medtronic s diabetes public relations director, denied there were problems with the supply set or that they were even addressed during the March conference. Madrid offered strong support for Vital s efforts to track down the problems on behalf of patients who frequently blamed themselves for unexplained high blood glucose levels. Pump therapy is great, Madrid said. It gives people a lot of flexibility with their blood sugar management and can help them stay more stable. But it s a note to self and to everyone in the field to check the device after examining the behavioral piece of the management. What they re worried about Pumps a Boon to Diabetes Management for the Vigilant Patient Insulin pumps help millions of diabetes patients manage their blood sugar. But they are complex instruments that have to be carefully checked and maintained, UCH diabetes educators said. To help control their blood sugar, Endocrinology Clinic Diabetes Educator Tavia Vital and more than 200 UCH Endocrinology Clinic patients use insulin pumps from one of three manufacturers: Medtronic which brought the first such device, the MiniMed, to market in 1983 OmniPod and Animas. About 80 percent of the UCH patients use a pump from Medtronic, Vital said. The pumps, controlled by microprocessors, deliver a programmed amount of insulin intermittently to the patient. They help to free the patient from selfadministering long-acting (basal) injections at regular intervals during the day and short-acting (bolus) injections before meals or when blood sugar levels spike. They deliver small doses of insulin a little at a time, 24 hours a day, to cover the sugar let out by the liver, and larger amounts when the user pushes buttons on the pump to counter a higher-than-target blood glucose level or when eating carbohydrates, Vital explained.

4 Volume 4 Issue 20 Through April 26, 2011 Page 4 Watching technology and diet. Using a pump, however, isn t a matter of opening a box and flipping a switch. For patients who decide to use one, the Endocrinology Clinic first provides extensive training, education and recordkeeping instruction, Vital said. Patients then select a pump brand and pick it up either directly from the manufacturer or from a third-party supplier. The hospital does not provide the pumps or the supplies. There are several kinds of supplies and parts to keep working and keep checking. A reservoir that holds the insulin fits inside the pump. An infusion set attached to the reservoir delivers intermittent doses of insulin the patient uses the device to calculate the amount through a flexible tube called a cannula that the patient inserts under the skin and secures in place with an adhesive. The patient changes out the reservoir and infusion set every two or three days. Seemingly small problems with the infusion set can cause blood sugar levels to fluctuate, said Vital, who has had a pump since The pointed end where the cannula enters the skin can bend over, the tubing can kink or air bubbles can be in the line, all of which can decrease or make erratic the flow of insulin. Scar tissue that forms after repeated insertions of the tubing can also thwart insulin delivery, so patients must regularly change the insertion site. And of course, the pump works best if patients also pay close attention to what they eat, when they eat it, and what they do after they eat exercise, control their stress and so on. You check all of these small details repeatedly, every day, said Vital. It takes time and energy to control blood sugars consistently, but if you re paying close attention and have a good understanding of your diabetes and how your medications work, you can predict when you ll have fluctuations and they won t happen as often. If they do, she added, the diligent patient often can deduce the reason. Maybe I just guessed on the number of carbs I had at lunch. That s something I can trace back to. A lot goes into blood sugar control. Some people have the time to focus their energy on it, some don t. The Company s Response The Insider made several efforts, beginning March 23, to contact Medtronic for comment about this story. Diabetes Public Relations Director Amanda Sheldon ultimately provided two separate responses. Medtronic, she wrote on April 8, is highly committed to upholding the highest quality and safety standards for our products, and takes prompt action when any potential issues are identified. In the case of our work with the team at the University of Colorado [Hospital], we immediately investigated the complaints we received through our standard quality review process. To date, our investigation, including testing of devices returned to us for analysis, has not revealed any product defects that would result in the patient adverse effects reported by the University of Colorado. The company, she added, found no evidence of defective lots of infusion sets. The University of Colorado team reported concerns regarding no delivery alarms. The alarms can often be cleared by disconnecting and reconnecting the infusion set. It is important to note that alarms, such as the no delivery alarm, serve an important function to alert users to change or reinsert the infusion set. Vital and Madrid acknowledged that the hospital had indeed reported instances of no delivery alarms which signal to the patient that the pump isn t delivering insulin among many other issues not covered by Sheldon s response. The Insider responded, noting that Sheldon s response did not conform to the information in this story, adding that both sources had reviewed the article for accuracy. We provided a section of the story that detailed the problems. Upon being told that Vital and Madrid contended that Medtronic s quality and products team members not only had discussed concerns about the supply set during the March conference call but had said they d been corrected, Sheldon maintained in an April 11 that Medtronic had only tried to ensure that the team is aware of best practices for the safe and effective use of insulin pump therapy.

5 Volume 4 Issue 20 Through April 26, 2011 Page 5 No defects. Sheldon then addressed the inaccuracies she claimed were contained in the short excerpt of the article the Insider sent to her for review. Our investigation, she reiterated, including testing of devices returned to us for analysis, has not revealed any product defects that would result in the patient adverse effects (including high blood glucose levels) reported by the University of Colorado [Hospital]. She also unequivocally denied, point by point, that the company had acknowledged during the March conference call any problems with pump supplies, including the reservoir cap, crooked needles or adhesive used to affix the infusion set. She went a step further, denying that any product complaints submitted by the UCH team involved failure of the snap cap of the reservoir crooked needles or infusion set adhesive. She did suggest, however, that improper alignment of the reservoir cap might be traced to the user. And she acknowledged manufacturing changes to the insulin reservoir needle, which we found to be shorter than the ideal height in a few cases. Shorter needles may cause a no [insulin] delivery alarm during prim[ing], which does not pose a patient safety issue. No risk. Finally, Sheldon said, the company recently discovered that some needles used to fill the insulin reservoir may be inclined, resulting in a small amount of spilled insulin during reservoir fill. The problem, she said, poses no patient safety risk and, she added, the patient is not connected to the pump during refill. Sheldon concluded by writing, I d like to reiterate that Medtronic investigated all the complaints through our standard quality review process and, to date, our investigation, including testing of devices returned to us for analysis, has not revealed any product defects that would result in the patient adverse effects (such as high blood glucose levels) reported by the University of Colorado [Hospital]. As is our normal process, we have continued to ask for any product that is of concern to be returned to our facility for further analysis. Asked for a response, Vital and Madrid said they stood behind their account of the March conference call, and that Medtronic officials who attended the call, including Cliff Kodama, the company s director of quality, reliability engineering and design assurance; and Anthony Vicente, a senior project analyst, acknowledged the pump-supply problems described in this article. In fact, she went on, the no delivery alarm (and other alarms), serve an important safety function, alerting users that they are currently not receiving insulin and, therefore, must change or reinsert the infusion set. Any customer who encounters this issue may call Medtronic s 24-hour helpline for a replacement. Subscribe: The Insider is delivered free via every other Wednesday. To subscribe: uch-publications@uch.edu Comment: We want your input, feedback, notices of stories we ve missed. To comment: uch-insiderfeedback@uch.edu