ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-15573
- Event Type
- Malfunction
- Date Received
- June 3, 2014
- Report Date
- May 28, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PATIENT
Narratives
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 07/17/2014-PRODUCT ANALYSIS:THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/09/2014 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE PEELING. EVALUATION REVEALED THAT THE OK AND DOWN KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS NO EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE KEY CONTACTS. CORROSION WAS OBSERVED ON THE KEYPAD FLEX CABLE. UNRELATED TO THE COMPLAINT, A DISPLAY LENS LEAK WAS DISCOVERED DURING LEAK TESTING. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE KEYPAD WAS DAMAGED, THE UP, DOWN, AND OK KEYPAD BUTTONS WERE UNDER-RESPONSIVE, AND THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN LENS. IT WAS ALLEGED THAT AN UNDER-DELIVERY OF INSULIN OCCURRED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323615 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |