OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
Report
- Report Number
- 3004464228-2022-21498
- Event Type
- Malfunction
- Date Received
- November 17, 2022
- Date of Event
- November 4, 2022
- Report Date
- November 10, 2022
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 10385082000139
- PMA / PMN Number
- K192659
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
A TECHNICAL ASSESSMENT OF THE DEVICE DESIGN IDENTIFIED THE ROOT CAUSE OF THE THERMAL EVENT TO BE THE DASH PDM CHARGING VOLTAGE EXCEEDING THE BATTERY SPECIFICATION, DEFINED AS OVERCHARGING. FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED BY INSULET CORPORATION. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.
A TECHNICAL ASSESSMENT OF THE DEVICE DESIGN IDENTIFIED THE ROOT CAUSE OF THE THERMAL EVENT TO BE THE DASH PDM CHARGING VOLTAGE EXCEEDING THE BATTERY SPECIFICATION, DEFINED AS OVERCHARGING. FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED BY INSULET CORPORATION. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.
IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) IS NOT HOLDING CHARGE. THE PDM WOULD HOLD CHARGE FOR 2-3 HOURS THEN IMMEDIATE DROP TO ALMOST 0%.
IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) IS NOT HOLDING CHARGE. THE PDM WOULD HOLD CHARGE FOR 2-3 HOURS THEN IMMEDIATE DROP TO ALMOST 0%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238516 | OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | PT-000010 | L000335 | 10385082000139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |