FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 5383636
·
Received January 21, 2016
Report
- Report Number
- 2531779-2016-02237
- Event Type
- Malfunction
- Date Received
- January 21, 2016
- Report Date
- January 7, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COMPLETED ON 01/07/2016. RETURNED TO MANUFACTURER ON 12/09/2015.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/07/2016 WITH THE FOLLOWING FINDINGS. ON INVESTIGATION, THE PUMP POWERED UP TO A DIM AND DISCOLORED VERIFY SCREEN. THE KEYPAD COVER WAS TORN BELOW THE ¿OK¿ BUTTON WHILE ALL THE BUTTONS WERE RESPONSIVE. REMOVAL OF THE KEYPAD COVER DID NOT FIND ANY CONTAMINATION UNDER THE BUTTON CONTACTS. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE DISPLAY WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON 01/07/201615.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40426 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |