BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2862886 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07396
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 13, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING THE METER WAS READING CONTROL SOLUTION INACCURATELY. THE REPORTER ALLEGED READINGS OF "6.9 MMOL/L" WITH CONTROL SOLUTION ON THE LFS METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY OR PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR