FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 1697388
·
Received May 12, 2010
Report
- Report Number
- 3004464228-2010-01123
- Event Type
- Malfunction
- Date Received
- May 12, 2010
- Date of Event
- March 24, 2010
- Report Date
- April 14, 2010
- 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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS BG LEVELS CONTINUED TO RISE DESPITE MULTIPLE BOLUS ATTEMPTS; HIGH READINGS RANGED FROM 252-386 MG/DL OVER THE COURSE OF A DAY. NO ALARM OR OTHER PRODUCT ISSUE WAS REPORTED. THE POD WAS REMOVED AND REPLACED AND WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 11200 | L30112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |