FDA Adverse Event
Death
Summary report: N
OMNIPOD INSULIN MANAGEMENT SYSTEM
MDR report key: 9346484
·
Received November 20, 2019
Report
- Report Number
- 3004464228-2019-12043
- Event Type
- Death
- Date Received
- November 20, 2019
- Date of Event
- November 15, 2019
- Report Date
- November 15, 2019
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 20385081120033
- PMA / PMN Number
- K162296
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. NO PRODUCT MALFUNCTION WAS ALLEGED. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO LOT RELEASE RECORDS WERE REVIEWED.
Additional Manufacturer Narrative · 1
PER NEW INFORMATION RECEIVED ON 1/14/2020, THE PATIENT DIED AT A SPORTS FIELD OF A HEART ATTACK AND NONE DIABETES RELATED ISSUES. THE PATIENT WAS NOT USING THE OMNIPOD SYSTEM AT THE TIME OF DEATH BUT A DIFFERENT PUMP (KALEIDO).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1145216 | OMNIPOD INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 19191 | 20385081120033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death |