FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
MDR report key: 16101984
·
Received January 5, 2023
Report
- Report Number
- 3004464228-2023-00376
- Event Type
- Malfunction
- Date Received
- January 5, 2023
- Date of Event
- December 29, 2022
- Report Date
- December 29, 2022
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 10385082000146
- PMA / PMN Number
- K192659
- 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'S (PDM) BATTERY WAS OVERHEATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827774 | OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | PT-000011 | L000265 | 10385082000146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Male |