ANIMAS VIBE
Report
- Report Number
- 2531779-2014-16841
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- June 9, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT MULTIPLE CS 087 CALL SERVICE ALARMS WERE RECORDED. DURING TESTING, THE PUMP POWERED ON AND EMITTED A CS 069 CALL SERVICE ALARM, WHICH IS INDICATIVE OF AN INTERNAL COMPONENT FAILURE ON THE PRINTED CIRCUIT BOARD. THE PUMP CASE WAS REMOVED AND A COMPONENT ON THE PRINTED CIRCUIT BOARD (U39 FLASH CHIP) WAS FOUND TO BE DEFECTIVE. THE PRINTED CIRCUIT BOARD COMPONENT WAS REPLACED AND THE PUMP FUNCTIONED APPROPRIATELY WITH NO ALARMS OCCURRING DURING TESTING. NO BATTERY CAP WAS RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS USED TO COMPLETE ALL 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.
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)(6).
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 A 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 |
|---|---|---|---|---|---|---|---|
| 350423 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |