BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3141479 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14148
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THE METER IS SHOWING A PC ON THE DISPLAY. PRIOR TO THE ONSET OF THE REPORTED ISSUE, THE PATIENT REPORTEDLY HAD SYMPTOMS DESCRIBED AS ¿DIZZY AND FELT BLOOD SUGAR PROBABLE LOW WITH HEADACHE.¿ THERE WAS NO REPORT OF ANY REQUIRED TREATMENT TO SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT¿S SYMPTOMS PRECEDED THE ONSET OF THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244341 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3437687

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR