BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGC ANTIBODY

    MDR report key: 1064998 · Received June 24, 2008

    Report

    Report Number
    1415939-2008-00201
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-6/06/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WIL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE RUBELLA CALIBRATION FAILED WITH ERROR CODE 1003: CALIBRATION CHECK FAILURE, CAL A, DEVIATION TOO LARGE, ON THE AXSYM ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA IGC ANTIBODY MEIA FOR THE MEASUREMENT OF IGG ANTIBODY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 58295M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AXSYM ANALYZER| RUBELLA-G CAL LIST# 9C29-01