FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5529624
·
Received March 28, 2016
Report
- Report Number
- 2531779-2016-06682
- Event Type
- Malfunction
- Date Received
- March 28, 2016
- Report Date
- March 8, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- MDS
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/08/2016 WITH THE FOLLOWING FINDINGS: THE PUMP BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE BUMPER PAD TRAVELING TOWARD THE CASE SEAL. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED 03/08/2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185116 | ANIMAS VIBE | INSULIN INFUSION PUMP | MDS | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |