FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3901375
·
Received June 30, 2014
Report
- Report Number
- 2531779-2014-18601
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Report Date
- June 25, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/25/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. UNRELATED TO THESE ISSUES, THE AUDIO BOLUS BUTTON COVER WAS DETACHED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY FAILURE AND DAMAGE TO THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/25/2014. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380926 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |