ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-19526
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Report Date
- July 5, 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.
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE AUDIO BOLUS BUTTON WAS MISSING. THERE WAS EVIDENCE OF CORROSION OBSERVED ON THE AUDIO BOLUS BUTTON CONTACTS. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND AT THE MISSING AUDIO BOLUS BUTTON. THE PUMP CASE WAS REMOVED AN NO EVIDENCE OF MOISTURE WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TO THE GRIP PAD. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS FADED AND DISCOLORED.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB DMG PRIOR TCTL CNG W/MOIST) ISSUE. THE REPORTER ALLEGED THAT THE AUDIO BOLUS BUTTON WAS MISSING/PEELING. ADDITIONALLY, MOISTURE/CORROSION WAS EVIDENT IN THE AUDIO BOLUS BUTTON AREA AND BEHIND THE DISPLAY. 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 |
|---|---|---|---|---|---|---|---|
| 405050 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |