FDA Adverse Event
Malfunction
Summary report: N
OMNIPON INSULIN PUMP
MDR report key: 3842647
·
Received February 25, 2014
Report
- Report Number
- 3004464228-2014-00225
- Event Type
- Malfunction
- Date Received
- February 25, 2014
- Date of Event
- January 27, 2014
- Report Date
- January 27, 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 EVAL. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT DEFECT OR DEFICIENCY COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE, A CONDITION THAT COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HIGH BLOOD GLUCOSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READ "HIGH" (>500 MG/DL OR 27.8 MMOL/L) LESS THAN A DAY AFTER THE POD WAS ACTIVATED AND THAT THE CANNULA WAS OUT OF HIS SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114874 | OMNIPON INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14810-5J | L40611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |