ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2013-11126
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- June 23, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PATIENT
Narratives
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.
THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/03/2013 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ¿ON¿ AND DISPLAYED ¿VERIFY¿ SCREEN; NO BLANK SCREEN WAS DUPLICATED. THE DISPLAY WAS DIM AND FADED. FADED SCREEN REMOVED AND REPLACE WITH A NEW TEST DISPLAY AND FOUND TO BE FULLY FUNCTIONAL. A LEAK TEST REVEALED A DISPLAY LENS LEAK. THE PUMP COVER WAS REMOVED AND MOISTURE CORROSION WAS OBSERVED ON LENS AND THE DISPLAY SCREEN FLEX. 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.
ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE SCREEN WAS BLANK. THE PATIENT WAS SWIMMING FOR 5 MINUTES. 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 |
|---|---|---|---|---|---|---|---|
| 333149 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |