BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2822668 · Received November 7, 2012

    Report

    Report Number
    3008382007-2012-06066
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 23, 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
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS NOT REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIO IQ METER READ INACCURATELY ERRATIC. THE PATIENT'S DAUGHTER REPORTED BLOOD GLUCOSE RESULTS OF "162 AND 126 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION 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 3329660

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR