FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6556532
·
Received May 10, 2017
Report
- Report Number
- 2531779-2017-09930
- Event Type
- Malfunction
- Date Received
- May 10, 2017
- Report Date
- April 21, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYO
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
ON (B)(6) 2017 , THE REPORTER CONTACTED ANIMAS, ALLEGING A CGM (DEX 007) ISSUE. IT WAS REPORTED THAT THE TRANSMITTER OUT OF RANGE ALERTS (CS 206) WERE DISPLAYED FOR MORE THAN THREE HOURS WHILE THE CGM WAS IN RANGE. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN THE USER MISSING THEIR BLOOD GLUCOSE (BG) TRENDING AND FAILING TO REACT TO ANY POTENTIAL BG EXCURSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339869 | ANIMAS VIBE | OYC | OYO | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |