FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3821381
·
Received April 25, 2014
Report
- Report Number
- 3004464228-2014-00540
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 29, 2014
- Report Date
- March 29, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
TIME: 11:06 AM. BLOOD GLUCOSE (MG/DL): 424. BOLUS (UNITS): 2.55U. TIME: 11:59 AM. BLOOD GLUCOSE (MG/DL): 337 - ATE 45G CARBS. BOLUS (UNITS): 2.35U. TIME: 2:45 PM. BLOOD GLUCOSE (MG/DL): 325. BOLUS (UNITS): 1.95U. THE CUSTOMER REPORTED THAT SHE WAS NERVOUS ABOUT HER HIGH BLOOD GLUCOSE READINGS, SO SHE TOOK THE POD OFF BECAUSE SHE DIDN'T THINK IT WAS WORKING FAST ENOUGH. WHEN SHE REMOVED THE POD, SHE NOTICED THAT THE CANNULA WAS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251835 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |