FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3941398
·
Received April 16, 2014
Report
- Report Number
- 3004464228-2014-00497
- Event Type
- Malfunction
- Date Received
- April 16, 2014
- Date of Event
- March 16, 2014
- Report Date
- March 19, 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
WHEN THE POD WAS REMOVED, THE CUSTOMER'S MOTHER NOTICED THAT THE CANNULA WAS BENT AND A "DOT" OF BLOOD WAS IN THE CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232604 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 MO |