FDA Adverse Event Malfunction Summary report: N

ONE TOUCH VERIO IQ BG METER

MDR report key: 4834851 · Received June 2, 2015

Report

Report Number
MW5043015
Event Type
Malfunction
Date Received
June 2, 2015
Date of Event
June 2, 2015
Report Date
June 2, 2015
Manufacturer
LIFESCAN
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

MY MED INSURANCE NO LONGER COVERS MY EXISTING METER. BECAUSE OF THIS, I HAD TO SWITCH TO A ONE TOUCH VERIO IQ METER. THE METER TESTS WILDLY HIGH. IF I HAD ACTED ON THE METER RESULTS, IT COULD HAVE HAD SERIOUS CONSEQUENCES. I HAVE TWO OLD METERS. BOTH OF THE OLD METERS TESTED ABOUT 50 TO 75 POINTS LOWER THAN THE ONE TOUCH VERIO IQ. I CALLED THE MFR; THEY SENT ME A REPLACEMENT METER - SAME RESULTS. I WENT TO AMAZON.COM AND READ THE NEGATIVE REVIEWS. A NUMBER OF PEOPLE ARE HAVING THE SAME RESULTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
357287 ONE TOUCH VERIO IQ BG METER ONE TOUCH VERIO IQ BG METER NBW LIFESCAN ONE TOUCH VERIO IQ

Patients

Seq Age Sex Outcome Treatment
1 50 YR ASPIRIN| JANUMET| VITAMINS| ZETIA| INVOKANA| FISH OIL