BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2170599 · Received July 21, 2011

    Report

    Report Number
    3008382007-2011-00044
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIOPRO METER WAS GIVING "APPLY SAMPLE" MESSAGE AND HE WAS UNABLE TO OBTAIN A READING. 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