FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6347763
·
Received February 21, 2017
Report
- Report Number
- 2531779-2017-03999
- Event Type
- Malfunction
- Date Received
- February 21, 2017
- Report Date
- February 2, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 2/02/2017 WITH THE FOLLOWING FINDINGS: DURING TESTING, IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS DIM AND DISCOLORED. UNRELATED TO THESE ISSUES, THERE WAS A SCRATCH NEAR THE REAR PACKAGE LABEL. THE BATTERY CAP AND CARTRIDGE CAP WERE NOT RETURNED WITH THE PUMP AND TEST CAPS WERE USED TO COMPLETE THE INVESTIGATION. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT AND A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 2/02/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129643 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |