BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO PLUS METER

    MDR report key: 6102069 · Received November 15, 2016

    Report

    Report Number
    3008382007-2016-59173
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Report Date
    November 7, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY LOW COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 23 MG/DL WITH THE SUBJECT METER AND 53 MG/DL ON THE LABORATORY DEVICE. THE TESTS WERE PERFORMED WITHIN AN UNKNOWN TIME OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS MAY HAVE EXCEEDED LIFESCANS CRITERIA FOR ACCURACY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755107 OT VERIO PRO PLUS METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1