FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5265082
·
Received December 3, 2015
Report
- Report Number
- 2531779-2015-43782
- Event Type
- Malfunction
- Date Received
- December 3, 2015
- Report Date
- November 19, 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 11/19/2015 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. UNRELATED TO THESE ISSUES, THE KEYPAD COVER WAS TORN AT THE OK BUTTON. (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 11/19/2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 793974 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |