FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5955660
·
Received September 16, 2016
Report
- Report Number
- 2531779-2016-25640
- Event Type
- Malfunction
- Date Received
- September 16, 2016
- Report Date
- August 19, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- UDI-DI
- 10840406100044
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. INITIAL REPORTER: (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 08/19/2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610023 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION | 10840406100044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |