FDA Adverse Event
Injury
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3911569
·
Received June 26, 2014
Report
- Report Number
- 3004464228-2014-00892
- Event Type
- Injury
- Date Received
- June 26, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 29, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO MALFUNCTION OR OTHER PRODUCT CONDITION THAT WOULD HAVE CONTRIBUTED TO REPORTED HOSPITALIZATION FOR HYPERGLYCEMIA WAS FOUND. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WAS TAKEN TO THE ER WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA, DEHYDRATION, AND KETONES. THE CUSTOMER WAS GIVEN IV FLUIDS FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373026 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Hospitalization |