FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 1250525
·
Received November 14, 2008
Report
- Report Number
- 3004464228-2008-00305
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- October 20, 2008
- Report Date
- October 20, 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 HE HAD HIGH BLOOD GLUCOSE LEVELS (BG'S) AFTER WEARING A POD FOR 4 HOURS. THE CUSTOMER'S BG'S FLUCTUATED BETWEEN 109 - 338 MG/DL BEFORE TAKING THE 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 | LZG | INSULET CORPORATION | 11200 | L30034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |