BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3230588 · Received July 16, 2013

    Report

    Report Number
    3008382007-2013-19944
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 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
    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 INACCURATE READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 566 MG/DL AND 94 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OR MEDICAL ATTENTION. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT¿S TESTING TECHNIQUE OR TEST STRIPS. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PATIENT EXPERIENCED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING 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
    328059 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3427304

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR