FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6026232
·
Received October 13, 2016
Report
- Report Number
- 2531779-2016-28384
- Event Type
- Malfunction
- Date Received
- October 13, 2016
- Report Date
- September 19, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- UDI-DI
- 10840406100051
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS E RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/19/2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED CONTAMINATION UNDER ALL KEYPAD BUTTON CONTACTS. THE KEYPAD COVER WAS FOUND TO BE PEELING; ALL KEYPAD BUTTONS WERE NORMALLY RESPONSIVE. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER THE KEYPAD BUTTONS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/19/2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677884 | ANIMAS VIBE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | 10840406100051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |