FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3925155
·
Received June 20, 2014
Report
- Report Number
- 3004464228-2014-00846
- Event Type
- Malfunction
- Date Received
- June 20, 2014
- Date of Event
- January 31, 2014
- Report Date
- June 3, 2014
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K122953
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED PRODUCT WAS EVALUATED AND THE INVESTIGATION FOUND EVIDENCE OF AN INTERNAL LEAK. ITS ROOT CAUSE WAS DETERMINED TO BE A LEAK AT RESERVOIR O RING. THE LEAKAGE THROUGH THE O-RING CONFIRMS THAT THE PROGRAMMED INSULIN DID NOT DELIVER SUFFICIENT AMOUNT OF INSULIN WHICH THEN CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HIS BLOOD GLUCOSE HISTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363424 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |