FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 1372522
·
Received February 20, 2009
Report
- Report Number
- 3004464228-2009-00134
- Event Type
- Malfunction
- Date Received
- February 20, 2009
- Date of Event
- February 2, 2009
- Report Date
- February 2, 2009
- Manufacturer
- INSULET CORPORATION
- Product Code
- ---
- 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'S MOTHER CALLED TO REPORT A POD SHE DID NOT THINK WAS WORKING PROPERLY. PARENT ALSO STATED HER DAUGHTER'S BLOOD GLUCOSE LEVELS (BGS) WERE ALL OVER THE PLACE WHILE WEARING THIS POD. HER BGS RANGED BETWEEN 112-489 MG/DL BEFORE TAKING THIS POD OFF AND STARTING A NEW ONE. NO FURTHER ISSUES WERE IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | --- | INSULET CORPORATION | 11200 | L30062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 MO | Other |