FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5243218
·
Received November 23, 2015
Report
- Report Number
- 2531779-2015-42571
- Event Type
- Malfunction
- Date Received
- November 23, 2015
- Report Date
- November 6, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/06/2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS DAMAGED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/06/2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772915 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |