BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1152605 · Received September 10, 2008

    Report

    Report Number
    1415939-2008-00242
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    November 14, 2007
    Report Date
    November 15, 2007
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE RUBELLA CALIBRATION FAILED WITH ERROR CODE ON THE AXSYM ANALYZER. THE CUSTOMER CHECKED THE REAGENT AND CALIBRATOR EXPIRATION DATES, MIXED THE CALIBRATOR AND RECALIBRATED THE ASSAY RESULTING IN AN ACCEPTABLE CALIBRATION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA IGG ANTIBODY MEIA FOR THE MEASUREMENT OF IGG ANTIBODY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 52563M100

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER