FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 1381439
·
Received March 10, 2009
Report
- Report Number
- 3004464228-2009-00165
- Event Type
- Malfunction
- Date Received
- March 10, 2009
- Date of Event
- February 12, 2009
- Report Date
- February 12, 2009
- 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 THAT SHE DID NOT THINK HER POD WAS WORKING PROPERLY BECAUSE HER BLOOD GLUCOSE LEVELS WERE ELEVATED AND RANGED BETWEEN 231-359 MG/DL WHILE WEARING THIS POD. CUSTOMER WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY. 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 | L30075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |