FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6970764
·
Received October 23, 2017
Report
- Report Number
- 2531779-2017-24511
- Event Type
- Malfunction
- Date Received
- October 23, 2017
- Report Date
- October 2, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/02/2017 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THE PUMP WAS POWERED ON AND THE DISPLAY WAS DIM AND DISCOLORED. 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. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. EVALUATION ALSO REVEALED A DIM, DISCOLORED DISPLAY. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/02/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747652 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |