ANIMAS VIBE
Report
- Report Number
- 2531779-2015-20131
- Event Type
- Malfunction
- Date Received
- June 17, 2015
- Report Date
- June 4, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- P130007
- 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.
FOLLOW-UP #1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/30/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA SHOWED PUMP REBOOTS OCCURRED. DURING A VISUAL INSPECTION OF THE PUMP, A BATTERY COMPARTMENT CRACK WAS OBSERVED ON THE SIDE AT THE THREADS. A LEAK TEST WAS PERFORMED AND BATTERY COMPARTMENT LEAK WAS FOUND. THE RETURNED BATTERY CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP WITH NO POWER LOSS OCCURRING. THE BATTERY CAP DIMENSION MEASUREMENTS WERE WITHIN SPECIFICATIONS. THE PUMP POWERED ON AND THE EZ-PRIME STEPS WERE PERFORMED WITH NO POWER INTERRUPTIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE INGRESS OR DAMAGE TO THE POWER CIRCUIT WAS FOUND. THE COMPLAINT OF INTERMITTENT POWER WAS SHOWN IN THE PUMP HISTORY BUT NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. (B)(4).
ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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 |
|---|---|---|---|---|---|---|---|
| 395320 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |