BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1152585 · Received September 10, 2008

    Report

    Report Number
    1415939-2008-00235
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 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 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 THAT, THE AXSYM RUBELLA IGG REAGENT CALIBRATION FAILED WITH ERROR CODE 1111: M-CAL 1 CHECK TOO HIGH, RUBELLA G, ON THE AXSYM ANALYZER. THE SYSTEM MAINTENANCE IS UP TO DATE AND NO OTHER ASSAYS ARE AFFECTED. THE CUSTOMER ATTEMPTED TO RECALIBRATED WITHOUT RESOLUTION. 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 53587M101

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER