FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER
MDR report key: 18666668
·
Received February 8, 2024
Report
- Report Number
- 3004464228-2024-04481
- Event Type
- Malfunction
- Date Received
- February 8, 2024
- Date of Event
- January 18, 2024
- Report Date
- February 8, 2024
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K211575
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) BATTERY HAS EXPANDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 812749 | OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | PT-000030 | L000314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female |