FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6984272
·
Received October 27, 2017
Report
- Report Number
- 2531779-2017-25082
- Event Type
- Malfunction
- Date Received
- October 27, 2017
- Report Date
- October 12, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- 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 10/12/20107 WITH THE FOLLOWING FINDINGS: THE BATTERY AND CARTRIDGE COMPARTMENTS WERE CRACKED. THE DISPLAY WAS DIM AND DISCOLORED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY AND CARTRIDGE COMPARTMENT WERE CRACKED. THE DISPLAY WAS ALSO DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/12/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764891 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |