FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3942938
·
Received July 17, 2014
Report
- Report Number
- 2531779-2014-20505
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Report Date
- July 10, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, THE KEYPAD WAS FOUND TO BE TORN. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THERE WAS NO EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE KEY CONTACTS.
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419718 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |