FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3800162
·
Received May 8, 2014
Report
- Report Number
- 2531779-2014-12965
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Report Date
- April 30, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/30/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. EVALUATION ALSO REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04/30/2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278342 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |