BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2970886 · Received February 21, 2013

    Report

    Report Number
    3008382007-2013-03327
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 25, 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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OBTAINING AN UNKNOWN ERROR MESSAGE WITH THE SUBJECT METER. PRIOR TO OBTAINING THE ERROR, THE PATIENT CLAIMED SHE HAD DEVELOPED A HEADACHE AND FELT LIGHTHEADED; HOWEVER, DENIED RECEIVING MEDICAL TREATMENT. 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. THE PATIENT WAS SYMPTOMATIC PRIOR TO WHEN THE ERROR STARTED AND THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LFS' CRITERIA OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77182 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1