FDA Adverse Event
Death
Summary report: N
OMNIPOD INSULIN MANAGEMENT SYSTEM
MDR report key: 12050751
·
Received June 23, 2021
Report
- Report Number
- 3004464228-2021-09991
- Event Type
- Death
- Date Received
- June 23, 2021
- Date of Event
- June 4, 2021
- Report Date
- June 10, 2021
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 20385081120033
- PMA / PMN Number
- K192659
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIED IN A CAR ACCIDENT. THE PATIENT WAS WEARING A POD AT THE TIME OF THE CRASH, BUT IT WAS DESTROYED IN A CAR FIRE. NO FURTHER DETAILS TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951541 | OMNIPOD INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 19191 | 20385081120033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Death |