FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6833179
·
Received August 30, 2017
Report
- Report Number
- 2531779-2017-19788
- Event Type
- Malfunction
- Date Received
- August 30, 2017
- Report Date
- August 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/02/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS POWERED ON AND REVEALED A DIM, DISCOLORED DISPLAY. 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 DIM, DISCOLORED DISPLAY. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 08/02/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609692 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |