FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3761131
·
Received December 31, 2013
Report
- Report Number
- 3004464228-2013-01625
- Event Type
- Malfunction
- Date Received
- December 31, 2013
- Date of Event
- December 3, 2013
- Report Date
- December 3, 2013
- 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 PRODUCT WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM ISSUE (FAILURE TO RETRACT), TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA OR TO DETERMINE THE ROOT CAUSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER'S MOTHER REPORTED HER DAUGHTER'S BLOOD GLUCOSE REACHED 310 MG/DL LESS THAN 4 HOURS AFTER THE POD WAS ACTIVATED. UPON FURTHER INSPECTION SHE NOTICED THE NEEDLE DID NOT RETRACT BACK INTO THE POD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682515 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |