FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 1137706
·
Received August 20, 2008
Report
- Report Number
- 3004464228-2008-00182
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- July 23, 2008
- Report Date
- July 23, 2008
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042792
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
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 IS 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
CALLER STATES BLOOD GLUCOSE (B/G) AT TIME OF POD CHANGE, 7:02 AM, WAS 168MG/DL. THE CUSTOMER'S B/G LEVELS ELEVATED UNTIL THEY REACHED HIGH (AT 7:19 PM). AT 7:19 PM CALLER CHANGED POD AND MANUALLY ENTERED A B/G OF 500MG/DL TO GET A CORRECTION BOLUS TO DELIVER. BY 10:09 PM B/G WAS DOWN TO 136MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 11200 | L11745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |