BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3102216 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10764
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    February 20, 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, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED LIFESCAN (LFS) IN THE USA ALLEGING THE METER WAS DISPLAYING INACCURATE HIGH READING OF "146 MG/DL" COMPARED TO "91 MG/DL" ON A ONETOUCH ULTRAMINI METER AND "93 MG/DL" ON A ONE TOUCH ULTRASMART METER. THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MADE A METER VS. ANOTHER METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE RESULTS DOES NOT MEETS LFS' CRITERIA FOR ACCURACY REPORTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203595 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1