Source – medicaldevice-network.com
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has voluntarily initiated a field action to notify customers worldwide about potential risks related to shortened battery life in its MiniMed™ 600 and 700 series insulin pumps. The action, which began on July 31, 2024, emphasizes the importance of following built-in pump alerts and alarms for battery status. Users are encouraged to contact Medtronic if they notice any changes in the pump’s battery life. This voluntary recall stems from reports received from customers indicating a potential issue with the pumps’ battery longevity.
Investigation and Findings
Medtronic launched an investigation after receiving reports from customers about a decrease in the battery life of their insulin pumps. The comprehensive analysis revealed that insulin pumps from the MiniMed™ 600 and 700 series that have been dropped, bumped, or otherwise subjected to physical impact—even just once—are at risk of having their internal electrical components damaged. This damage can cause the pump’s battery life to shorten, resulting in battery alerts being triggered when less battery life remains than stated in the User Guide.
The most significant concern is that this electrical issue can cause the pump to stop delivering insulin earlier than expected, increasing the risk of hyperglycemia (elevated blood sugar levels) or diabetic ketoacidosis (DKA), a serious condition that could require medical intervention. Medtronic has received 170 reports of hyperglycemia (blood sugar levels over 400 mg/dL) and 11 reports of DKA between January 2023 and September 2024 in the U.S., potentially linked to this issue.
The U.S. Food and Drug Administration (FDA) has classified this field action as a Class I recall, the most serious type of recall, indicating that the use of the device may pose a risk of serious injury or death.
Customer Notification and Recommendations
Medtronic has updated its notification to customers, providing important guidance to ensure patient safety and prevent any disruption in insulin delivery:
- Physical Impact Risk: Even a single drop of the insulin pump can result in reduced battery life, either immediately or over time. This issue persists even after replacing the battery.
- Battery Alerts: The pump will still generate battery alerts and alarms, but users may receive these alerts with less battery life remaining than usual. This could lead to the pump stopping insulin delivery sooner than expected. Users should be prepared to replace the battery immediately after the “Low Battery Pump” alarm sounds.
- Always Carry Extra Batteries: Medtronic advises users to carry an extra set of new AA lithium, alkaline batteries, or fully charged NiMH (nickel-metal hydride) batteries. This ensures that users can quickly replace the battery if it depletes faster than expected.
- Notifying Medtronic: Users who observe a significant reduction in their insulin pump’s battery life, regardless of whether the pump has been dropped or physically impacted, should contact their local Medtronic team. In the U.S., customers can call 1-800-378-2292 for 24-hour technical support. International customers can find contact details for their local Medtronic support team through the company’s website.
- Back-up Therapy: Medtronic advises users to have a backup therapy plan in place, such as insulin injections, in case the pump experiences a failure and insulin delivery is disrupted.
Medtronic’s Commitment to Safety
“Medtronic began proactively notifying affected pump users in July due to the high priority we place on patient safety and recognizing the critical role insulin pumps play in managing diabetes,” said Dr. Robert Vigersky, Chief Medical Officer of Medtronic Diabetes. “We are here 24/7 to support our customers who may experience battery depletion or any other issues with their pumps. Patient safety is our top priority, and we are committed to ensuring continuity of therapy. This is why we have voluntarily notified patients and will replace pumps when necessary.”
Medtronic continues to emphasize the importance of promptly addressing any concerns users may have with their insulin pumps. The company’s global customer support team is available around the clock to provide assistance and replace pumps as needed.
Expansion of AI-Enabled Solutions
Medtronic has also made strides in developing innovative solutions for diabetes management. Earlier this year, the company collaborated with Qualcomm Technologies to introduce an AI-enabled Multi-Modal Intelligent Agent. This technology allows workers in industries like distribution and retail to interact with handheld devices using voice commands, images, and video. By 2025, Medtronic plans to integrate this technology into its Field Process Knowledge System (PKS), further advancing automation and connectivity across its product lines, including insulin pumps.
About Medtronic Diabetes
Medtronic is committed to transforming diabetes care by expanding access to technology, integrating care solutions, and improving patient outcomes. The company aims to empower people with diabetes to enjoy greater freedom and better health through its advanced technologies. For more information on the company’s diabetes business, visit Medtronic Diabetes.
About Medtronic
Medtronic plc, headquartered in Galway, Ireland, is a leading global healthcare technology company dedicated to addressing the world’s most challenging health problems. The company’s mission is to alleviate pain, restore health, and extend life. With over 95,000 employees across more than 150 countries, Medtronic’s technologies and therapies treat 70 different health conditions, including cardiac devices, insulin pumps, surgical robotics, and patient monitoring systems.
For more information on Medtronic, visit Medtronic’s official website and follow the company on LinkedIn for updates on their latest innovations and news.
