BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2940216 · Received February 2, 2013

    Report

    Report Number
    3008382007-2013-02008
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    January 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING A ONETOUCH VERIO PRO METER WAS DISPLAYING AN APPLY SAMPLE MESSAGE. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45466 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3331323

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR