Insulet is recalling the Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) due to the risk of battery swelling, leakage, or extreme overheating
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can result in serious injury or death.
- Product Name: Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM)
- Product models:
- 18239 ASM Omnipod DASH PDM
- PT-000010: Assembly, DASH Final PDM U100, mg/dL
- PT-000011: Assembly, DASH Final PDM U100, mmol/L
- Serial Numbers: All serial numbers
- Distribution dates: July 27, 2018 to August 31, 2022
- Devices recalled in the US: 248,288
- Date of Company Initiation: October 17, 2022
The Omnipod DASH Insulin Management System is used to deliver insulin at fixed and variable rates to treat diabetes in people who require insulin. It consists of two main parts: the wearable and tubeless pump that delivers the insulin, called a Pod, and a remote control called the Personal Diabetes Manager (PDM). The PDM is a small, reusable, rechargeable, battery-powered, locked Android handheld device with similar functionality to a smartphone. The pod is controlled solely via the PDM and the two parts interact wirelessly via secure Bluetooth.
reason for the recall
Insulet is recalling the Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including:
- Battery swelling
- Liquid leakage from the battery
- Extreme overheating which can pose a fire hazard
Users could be exposed to battery fluid and extreme heat, including the possibility of an explosion and/or fire, which could result in serious injury or death.
Insulet reports 455 complaints related to these battery issues, including three fires. There were no reports of injuries or deaths.
Who can be affected
- People who manage insulin levels with the Omnipod DASH Insulin Management System PDM.
- Healthcare providers with patients managing their insulin levels using the Omnipod DASH Insulin Management System PDM.
What to do
On October 17, 2022, Insulet sent users an email and letter regarding urgent medical device correction. The letter recommended the following actions for the Omnipod DASH Insulin Management System PDM:
- Monitor the DASH Insulin Management System PDM for any of the following issues:
- Back cover bulges or won’t close. Do not put pressure on the back cover if it is deformed in any way. The gel skin of the PDM must be removed to observe these issues, but do not remove the back cover.
- Extreme overheating (which may pose a fire hazard) or odor nuisance during charging, use, or storage.
- The device turns off immediately after being removed from the charger or does not turn on within 45 minutes after connecting to the charger.
- Battery discharges very quickly (Faster than usual) or it takes more than 1.5 hours to reach 80% charge.
- If the above problems occur:
- Stop using the system and do not charge the Omnipod DASH Insulin Management System PDM.
- Switch to a backup insulin plan as soon as possible.
- Contact the customer service team immediately at 1-800-641-2049 to request a temporary replacement device.
- If the above problems do NOT occur:
- Continue to use the Omnipod DASH Insulin Management System PDM, but always check the PDM before charging to ensure there are no signs of battery problems.
- Never remove the battery even if it is recommended by the user manual. Instead, call the customer service team at 1-800-641-2019 for instructions.
- Do not charge the DASH PDM above 85%. for free. Stop charging once the device reaches 85%.
- Do not charge the PDM:
- In environments with temperatures of 31 °C (87 °F) or higher
- In direct sunlight
- Do not use or charge the PDM if it feels unusually warm.
- Do not use the PDM while charging.
The company advises that users do not need to call customer service to obtain an updated Omnipod DASH Insulin Management System PDM – these devices will ship to all existing customers in the coming months as they become available. This includes users who have received temporary PDMs.
Users with questions can visit the Insulet website at www.omnipod.com/insulet-alerts or call 1-800-641-2049 to speak to the Insulet customer service team 24 hours a day, 7 days a week.
How do I report an issue?
Healthcare professionals and consumers may report adverse events or quality issues they have experienced while using these devices to MedWatch: the FDA Safety Information and Adverse Event Reporting Program by using an online form, mail, or FAX.