Medtronic Lead Nation in 2013 Class I Recalls
Medtronic, Inc. is a giant medical device manufacturer. One of the biggest in the world in fact. Based on its size, Medtronic has the capabilities to ensure that its products are safe and effective before putting them on the market. Unfortunately, that does not appear to be the case. In fact, in 2013, Medtronic lead the nation in FDA Class I recalls.
Medtronic has a long track record of recalling its products for safety defects, including defects in its insulin delivery products for type I diabetics. These products include insulin pumps and infusion sets. Insulin pumps are complex, electronic devices that send insulin to patients’ bodies through plastic tubing called infusion sets. Insulin pumps were invented so that type I diabetics could live a relatively normal life without being frequently interrupted by the pain and hassle of daily insulin injections.
Insulin delivery systems come with a downside, however. Unlike a standard syringe, insulin pumps are controlled by a computer chip that determines how much insulin in the pump’s reservoir to deliver to the user. When diabetics control their blood sugar the old-fashioned way with a syringe, they are able to personally control the dosage. That means they will only receive whatever amount of insulin they have injected into themselves. An insulin pump, in contrast, contains a reservoir of insulin that is dosed based on the users input, or the pump’s continuous glucose monitoring function. The user has to rely on the pump’s complex hardware and software to deliver the proper dose of insulin after it has been programmed. If there is a defect in just one of several pieces of the pump and infusion set system, it is possible that the entire contents of the insulin reservoir could be injected into the user, causing fatal hypoglycemia.
It is clear why proper safety controls and product design are paramount for insulin delivery products because accurate dosing is a matter of life our death for diabetics. On June 26, 2009, Medtronic issued a recall for Lot 8 of its Paradigm Quick-set infusion sets because it discovered that these infusion sets may deliver too much or too little injury and cause serious injury or death. At the time of the recall, Medtronic stated that only those lots were affected and stressed that “All Medtronic infusion sets other than ‘Lot 8’ Paradigm Quick-set infusion sets are fine to use. However on June 7, 2013, Medtronic issued a comprehensive recall for all of its infusion sets, stating that all of its infusion sets could cause fatal hypoglycemia or hypoglycemia.
This year, the FDA reported that Medtronic issued a recall for 560,000 units of its MiniMed Paradigm insulin pumps. Medtronic issued the recall because it discovered that the pump software is capable of causing a delivery of the entire reservoir of insulin. In their statement, Medtronic said the recall is due to a “button pressing error.” This language implies the insulin pumps are being recalled because of user error, not a problem with the device itself. As one of the world’s largest leading manufacturers of insulin pumps and infusion sets, it is Medtronic’s responsibility to perform human factors tests to determine whether “button pressing errors” are possible with the insulin pump software. Ideally, Medtronic would design and disseminate software to prevent foreseeable button press mistakes from seriously injuring insulin pump users.
In light of these recent recalls, it is extremely important to educate the public at large. If you or someone you know uses Medtronic insulin pumps and infusion sets, we encourage you to share this information with them. As stated before, for some users, this information could be a matter of life or death.
Ashcraft & Gerel is investigating serious injuries caused by faulty Medtronic insulin pumps and infusion sets. Please contact today online or by calling 800-829-7037 for a free consultation.