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 |