FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5243339
·
Received November 23, 2015
Report
- Report Number
- 2531779-2015-42568
- Event Type
- Malfunction
- Date Received
- November 23, 2015
- Report Date
- November 6, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- 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 11/06/2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE BATTERY CAP¿S COIN SLOT WAS DAMAGED, MAKING THE CAP DIFFICULT TO REMOVE. UNRELATED TO THE BATTERY CAP ISSUE, INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS MISSING. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY CAP WAS DAMAGED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/06/2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772514 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |