FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 4629154
·
Received March 24, 2015
Report
- Report Number
- 2531779-2015-09816
- Event Type
- Malfunction
- Date Received
- March 24, 2015
- Report Date
- March 9, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/09/2015 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS PEELING FROM THE BASE. ALL OF THE KEYPAD BUTTONS WERE RESPONSIVE DURING THE INVESTIGATION. CONTAMINATION WAS FOUND UNDERNEATH THE KEYPAD CONTACTS. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE KEYPAD BUTTON CONTACTS HAD CONTAMINATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/09/2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196073 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |