FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 4231696
·
Received October 14, 2014
Report
- Report Number
- 3004464228-2014-01534
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 16, 2014
- Report Date
- September 16, 2014
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K122953
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE REACHED 22.8 MMOL/L (410 MG/DL) LESS THAN 24 HRS AFTER THE POD WAS ACTIVATED AND HE NOTICED THE CANNULA WAS KINKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648719 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14810-5J | L40932 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |