ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2013-09017
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- June 1, 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
FOLLOW UP #1 SUBMITTED: 08/28/2013, ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE EVALUATION: ON EXAMINATION, THERE WAS VISIBLE MOISTURE BEHIND THE DISPLAY SCREEN. ON TESTING, THE PUMP POWERED ON WITH A BLANK DISPLAY SCREEN. A LEAK TEST WAS PERFORMED AND A CRACK WAS DISCOVERED IN THE PUMP CASE. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE INSIDE THE PUMP.
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.
ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) ISSUE. THE REPORTER STATED THAT THE DISPLAY SCREEN WAS GRADUALLY DIMMING OVER TIME AND DIFFICULT TO READ. THE REPORTER NOTED THAT AFTER BEING EXPOSED TO WATER THE DISPLAY SCREEN THEN BECAME CLOUDY. 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 |
|---|---|---|---|---|---|---|---|
| 291571 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |