BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2897190 · Received January 4, 2013

    Report

    Report Number
    3008382007-2013-00081
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 9, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE USER IN (B)(6) CONTACTED LIFESCAN TO REPORT ERROR 4 ERROR MESSAGE WITH THE ONE TOUCH VERIO PRO METER. THE ISSUE WAS NOT RESOLVED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5243 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1