FDA Adverse Event
Death
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 7013623
·
Received November 9, 2017
Report
- Report Number
- 3004464228-2017-06170
- Event Type
- Death
- Date Received
- November 9, 2017
- Date of Event
- October 26, 2017
- Report Date
- October 30, 2017
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K122953
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2017. THERE WAS NO FURTHER INFORMATION PROVIDED. ATTEMPTS WERE MADE TO CONTACT THE DIABETES NURSE TO PROVIDE ADDITIONAL INFORMATION AND SHE WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792078 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |