BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3171010 · Received June 14, 2013

    Report

    Report Number
    3008382007-2013-17282
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PRO METER WAS GIVING INACCURATE READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 80 MG/DL ON THE REPORTED METER AND A LABORATORY RESULT OF 60 MG/DL. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OR MEDICAL ATTENTION. AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-LAB ACCURACY 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
    270690 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3310820

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR