FDA Adverse Event
Injury
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 4202256
·
Received October 15, 2014
Report
- Report Number
- 3004464228-2014-01539
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 16, 2014
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K122953
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR DIABETIC KETOACIDOSIS. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. SHE WAS SUFFERING FROM NAUSEA, AND VOMITING BEFORE GOING TO THE HOSPITAL. SHE WAS TREATED WITH AN INSULIN DRIP, PHENERGAN, AND BENADRYL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654247 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L41216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization |