Drug Safety Alerts

Omnipod DASH® Personal Diabetes Managers (PDMs) Medical Device Correction

10/17/2022

On October 17, 2022 Insulet Corporation announced a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally.

Insulet received reports from Omnipod DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire. Insulet has advised that its investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death.

According to Insulet, there have been 50 complaints about this issue, and no serious injuries or deaths have been reported as a result of this potential issue.

According to Insulet, as previously communicated to Omnipod DASH users, it has identified an update to the Omnipod DASH PDM that will resolve this issue, and the company expects to begin shipping updated Omnipod DASH PDMs to all current Omnipod DASH customers in the coming months.

CVS/Caremark® Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

If you have questions, please call Insulet’s dedicated Customer Care team at 1-800-641-2049, which is available in the U.S. 24 hours a day, 7 days a week.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.