FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3822312
·
Received May 20, 2014
Report
- Report Number
- 2531779-2014-14229
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Report Date
- May 13, 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 05/13/2014 WITH THE FOLLOWING FINDINGS:THE KEYPAD COVER WAS FOUND TO BE TORN BETWEEN THE UP ARROW AND DOWN ARROW. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE DOWN ARROW BUTTON CONTACT. EVALUATION ALSO REVEALED THAT THE DISPLAY WAS DIM/FADING/DISCOLORED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM/FADING/DISCOLORED. INVESTIGATION ALSO REVEALED THAT THERE WAS CONTAMINATION UNDER THE DOWN ARROW BUTTON CONTACT. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/13/2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298596 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |