FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3843560
·
Received February 11, 2014
Report
- Report Number
- 3004464228-2014-00177
- Event Type
- Malfunction
- Date Received
- February 11, 2014
- Date of Event
- January 15, 2014
- Report Date
- January 15, 2014
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042792
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE DAMAGED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HIS BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 2:36 AM, BG(MMOL/L) 21.3, MG/DL: 383. TIME: 2:37AM, BOLUS (U): 7.4. TIME: 6:23AM, BG (MMOL/L) 19.1, (MG/DL): 344, BOLUS (U): 5.7. AT 6:55 AM THE POD WAS DEACTIVATED AND HE NOTICED THE CANNULA LOOKS TWISTED. THERE WAS ALSO INSULIN LEAKING AROUND THE POD SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90583 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L31116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |