ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-16852
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- June 10, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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.
(B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, MOISTURE WAS OBSERVED BEHIND THE PUMP DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON WITH AUDIBLE TONES AND VIBRATION; HOWEVER, THE DISPLAY SCREEN WAS BLANK DUE TO MOISTURE DAMAGE. A LEAK TEST WAS PERFORMED AND PASSED WITH NO LEAK IDENTIFIED. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE INGRESS WAS FOUND THROUGHOUT THE PUMP INTERIOR.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED AN UNIDENTIFIED CALL SERVICE ALARM AFTER THE USER NOTICED MOISTURE BEHIND THE DISPLAY LENS. THE PUMP ALLEGEDLY LOST POWER FOLLOWING THE CALL SERVICE ALARM. 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 |
|---|---|---|---|---|---|---|---|
| 351025 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |