BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2990808 · Received March 5, 2013

    Report

    Report Number
    3008382007-2013-04267
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 3, 2013
    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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LAY USER/PATIENT IN THE USA CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 176 MG/DL ON THE REPORTED METER AND A READING OF 88 MG/DL ON ANOTHER METER. INFORMATION REGARDING THE TIME DIFFERENCE BETWEEN THE TESTS WAS NOT AVAILABLE. AT THE TIME OF THE CALL, THE PATIENT STATED THAT THEY EXPERIENCED SYMPTOMS OF "HYPOGLYCEMIA", BUT DENIED SEEKING ANY MEDICAL ATTENTION OR TREATMENT. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92947 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR