FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3457863
·
Received November 8, 2013
Report
- Report Number
- 2531779-2013-20084
- Event Type
- Malfunction
- Date Received
- November 8, 2013
- Report Date
- October 25, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/25/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, STRIPPED THREADS WERE FOUND IN THE BATTERY COMPARTMENT. THE BATTERY CAP HAD STRIPPED THREADS AND THE CONTACT HEIGHT WAS FOUND TO BE OUT OF SPECIFICATIONS.
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS DAMAGED AND THERE WAS DAMAGE TO THE BATTERY CAP. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/25/2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579484 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |