ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2013-11638
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Report Date
- June 27, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
FOLLOW-UP # 1 DATE OF SUBMISSION 09/16/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/28/2013 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN WAS CLEAR AND LEGIBLE WITH MOISTURE OBSERVED BEHIND THE LENS. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND DUE TO A CRACK IN THE PUMP CASE. THE PUMP CASE WAS OPENED AND MOISTURE WAS FOUND THROUGHOUT THE PUMP INTERIOR.
ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DISPLAY ISSUE) ISSUE. THE PATIENT REPORTED SEEING MOISTURE BEHIND HALF OF THE DISPLAY SCREEN. THE PATIENT REPORTED NO CRACKS IN PUMP HOUSING OR LCD SCREEN, NO POWER LOSS, OR NO VISIBLE MOISTURE IN BATTERY COMPARTMENT; BATTERY CAP IS SECURE AND INTACT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340809 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |