BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2165766 · Received July 17, 2011

    Report

    Report Number
    3008382007-2011-00017
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Report Date
    June 14, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K093745.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN TO REPORT HE WAS UNABLE TO SET THE DATE/TIME SETTING CORRECTLY ON THE ONE TOUCH VERIOPRO METER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT SUFFERED NO INJURY DUE TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR