BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2830208 · Received November 13, 2012

    Report

    Report Number
    3008382007-2012-06352
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 29, 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
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    METER SERIAL NUMBER: NOT PROVIDED. LOT NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH VERIOIQ METER WAS GIVING INACCURATELY HIGH READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 204 MG/DL ON THE REPORTED METER, AND THE LABORATORY RESULT OF 135 MG/DL WITHIN AN UNSPECIFIED TIME PERIOD. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S TEST STRIPS OR TESTING TECHNIQUE. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS ISSUE. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. 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
    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 42 YR