BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIOVUE METER

    MDR report key: 5855074 · Received August 8, 2016

    Report

    Report Number
    3008382007-2016-38856
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    July 21, 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

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE SUBJECT DEVICE ((B)(4)) WHICH WAS PROVIDED IN THE INITIAL 3500A REPORT WAS INCORRECT. THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS THE SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING UNIT POWERS OFF DURING USE. 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
    507659 OT VERIOVUE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1