BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3022159 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06282
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 6, 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
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY ERRATIC READINGS. THE REPORTER WAS UNABLE TO PROVIDE ANY SPECIFIC DATA. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S TEST STRIPS OR TESTING TECHNIQUE. THE PATIENT EXPERIENCED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PATIENT EXPERIENCED NO SYMPTOMS AND HE DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE INACCURACY ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124224 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1