FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3963847
·
Received May 20, 2014
Report
- Report Number
- 3004464228-2014-00688
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- January 10, 2014
- Report Date
- May 9, 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 NO EVIDENCE OF ANY MANUFACTURING DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO 30+ UNITS OF INSULIN IN SIZE, WAS FOUND IN THE INSULIN RESERVOIR. AS THERE WAS NO EVIDENCE THAT THE USER ATTEMPTED TO REMOVE RESIDUAL INSULIN, THIS WAS MOST LIKELY INTRODUCED DURING THE FILL PROCESS. USE ERROR IS THEREFORE DETERMINED TO BE THE ROOT CAUSE OF HIGH BLOOD GLUCOSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HER BLOOD GLUCOSE REACHED 382 MG/DL LESS THAN 24 HOURS AFTER THE POD WAS ACTIVATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298244 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |