FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6032557
·
Received October 16, 2016
Report
- Report Number
- 2531779-2016-28659
- Event Type
- Malfunction
- Date Received
- October 16, 2016
- Report Date
- September 27, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- MDS
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/27/2016 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE DISPLAY SCREEN WAS DIM AND DISCOLORED. UNRELATED TO THESE ISSUES, THE AUDIO BOLUS BUTTON WAS MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. (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 SCREEN WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/27/2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683851 | ANIMAS VIBE | INSULIN INFUSION PUMP | MDS | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |