FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 7078176
·
Received December 3, 2017
Report
- Report Number
- 2531779-2017-27412
- Event Type
- Malfunction
- Date Received
- December 3, 2017
- Report Date
- November 6, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURN IS NOT REQUIRED. (B)(4).
Additional Manufacturer Narrative · 1
FOLLOW UP # 1: MODEL NUMBER; THE CORRECT MODEL NUMBER IS 9500-35.
Description of Event or Problem · 1
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CGM (DEX 012) ISSUE. IT WAS REPORTED THAT THE CONTINUOUS GLUCOSE MONITORING (CGM) READINGS WERE INACCURATE AS COMPARED TO THE FINGER STICK BLOOD GLUCOSE (BG) VALUES. 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 REACTING TO INCORRECT CONTINUOUS GLUCOSE MONITORING DATA WHICH MAY LEAD TO BG EXCURSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857138 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |