FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6357189
·
Received February 24, 2017
Report
- Report Number
- 2531779-2017-04342
- Event Type
- Malfunction
- Date Received
- February 24, 2017
- Report Date
- February 2, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- 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 02/02/2017 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY WAS DIM AND DISCOLORED. UNRELATED TO THESE ISSUES, THE KEYPAD WAS PEELING AND TORN OFF. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 02/02/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141267 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |