FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3811538
·
Received May 15, 2014
Report
- Report Number
- 2531779-2014-13562
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Report Date
- May 6, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/2014 WITH THE FOLLOWING FINDINGS: THE UP BUTTON WAS INTERMITTENTLY UNRESPONSIVE TO TESTING DUE TO A TORN KEYPAD. THE KEYPAD COVER WAS REMOVED FOR FURTHER INVESTIGATION AND THERE WAS NO CONTAMINATION FOUND UNDER ANY OF THE KEYPAD CONTACTS. UNRELATED TO THE KEYPAD ISSUE, THE PUMP BOOTED TO A DIM DISPLAY. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED INTERMITTENT FUNCTIONALITY OF THE UP KEYPAD BUTTON DUE TO A TORN KEYPAD AND A DIM DISPLAY. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/06/2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290221 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |