After receiving numerous customer reports of adverse health events, Medtronic plc of Ireland is issuing an urgent notification with updated instructions for its MiniMed™ 600 and 700 series insulin pumps. Due to the potential risk to consumers, the FDA is referring to Medtronic’s notification as a Class 1 recall.
In January of 2023, Medtronic began to receive reports about significantly impaired battery life for the MiniMed™ 600 and 700 series insulin pumps, especially those devices that had been dropped or bumped. The company determined that the impact of such falls likely caused internal damage to the machines. As a result of this damage, the built-in battery alarms for the MiniMed™ 600 and 700 series insulin pumps often overestimate the remaining battery life of the devices. This has caused many customers to lose power unexpectedly, halting the delivery of insulin to the patient. In sum, Medtronic has received 170 reports of hyperglycemia (>400mg/dL) and 11 reports of diabetic ketoacidosis caused by insufficient insulin levels.
In response to such reports, Medtronic plc issued a warning to consumers, advising that any impact or fall can damage the pump and result in reduced battery life. For this reason, consumers using a pump that has been dropped or damaged should replace the pump batteries immediately when the device’s low-battery alert sounds. The built-in alerts may not reflect the true amount of battery remaining in the device. Pump users should carry a back-up pump or insulin delivery system in case of device failure. Additionally, consumers should always carry batteries that are compatible with their MiniMed™ 600 or 700 series insulin pump.
Customers who have noticed battery impairment with their MiniMed™ 600 or 700 series insulin pump, or who have questions about the recall can contact Medtronic at 1-800-378-2292 for technical support or to discuss a replacement.
Patients and health care providers can report any new adverse health events related to Medtronic’s MiniMed™ 600 and 700 series insulin pumps through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome caused by a defective insulin pump, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent further injury to patients with diabetes. Our experienced attorneys at TruLaw are prepared to learn about your story and help you build a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.