FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5254973
·
Received November 30, 2015
Report
- Report Number
- 2531779-2015-43208
- Event Type
- Malfunction
- Date Received
- November 30, 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: DURING TESTING, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. UNRELATED TO THIS ISSUE, THE AUDIO BOLUS BUTTON COVER WAS DETACHED. THE BUTTON¿S RESPONSIVENESS COULD NOT BE TESTED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED DAMAGE TO THE BATTERY COMPARTMENT. 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 |
|---|---|---|---|---|---|---|---|
| 784939 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |