FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN POD
MDR report key: 3830175
·
Received May 12, 2014
Report
- Report Number
- 3004464228-2014-00640
- Event Type
- Malfunction
- Date Received
- May 12, 2014
- Date of Event
- April 7, 2014
- Report Date
- April 13, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM TO PROPERLY DEPLOY THE CANNULA OR TO DETERMINE ITS 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 400 MG/DL LESS THAN A DAY AFTER THE POD WAS ACTIVATED AND THEN SHE REALIZED THE NEEDLE NEVER INSERTED THE CANNULA INTO THE INFUSION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283343 | OMNIPOD INSULIN POD | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |