FDA Adverse Event
Death
Summary report: N
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
MDR report key: 14674488
·
Received June 13, 2022
Report
- Report Number
- 3004464228-2022-09480
- Event Type
- Death
- Date Received
- June 13, 2022
- Date of Event
- May 14, 2022
- Report Date
- May 27, 2022
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 20385082000020
- PMA / PMN Number
- K192659
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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 AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT WAS FOUND DISEASED WEARING A POD. THE PATIENT WAS FOUND TO HAVE HIGH BLOOD GLUCOSE LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1248428 | OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 18320 | 20385082000020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Death |