FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 1208525
·
Received October 17, 2008
Report
- Report Number
- 3004464228-2008-00257
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042792
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED PRODUCT EVALUATION CONFIRMED AN INTERNAL LEAK WHICH CAUSED DAMAGE TO THE DEVICE AFTER BEING FILLED WITH INSULIN. THE USER IS INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THIS RECOMMENDATION, THE USER WAS AWARE OF HIGH BG LEVELS AND WAS ABLE TO START A NEW POD SUCCESSFULLY. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
CUSTOMER CALLED TO REPORT HIS BLOOD GLUCOSE (BG) WAS HIGH AND DID NOT KNOW WHY. HE PLACED THIS POD IN 2008 AT 10:30 PM. HIS BG'S RANGED BETWEEN 233-299 MG/DL OVER NIGHT AND HE FINALLY DEACTIVATED THE POD AT 1:36PM THE NEXT DAY. HE SUCCESSFULLY PLACED A NEW POD. NO FURTHER ISSUES WERE IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 11200 | L11641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |