BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061577 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00097
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 6, 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
    NJ, US
    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 CONTACTED ABBOTT REPORTING THEY WERE UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY TWICE AND OBSERVED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A RESULT TOO HIGH) AND 3057 (AIR DURING ASPIRATION, BUFFER WELL, PROCESSING PROBE). THE CUSTOMER WAS ADVISED TO INSPECT PROCESSING PROBE FOR DAMAGE, AND PERFORM OTHER TROUBLESHOOTING PROCEDURES. AFTER TROUBLESHOOTING, THE CUSTOMER ACHIEVED SUCCESSFUL CALIBRATION. AS THE CUSTOMER OBTAINED FOUR PT RESULTS IN THE "GRAY" ZONE FOR POSITIVE INTERPRETATION, THE CUSTOMER PERFORMED PRECISION STUDY WITH THE AXSYM RUBELLA POSITIVE CONTROL AND A "GRAY" ZONE PT SAMPLE. THE CUSTOMER STATED PT 3 INITIAL RESULT WAS 9.1 IU/ML, THE REASSAY VALUE IS UNKNOWN. AS THE PT RESULT VERIFIED IN THE "GRAY" ZONE, THE CUSTOMER WAS SATISFIED THE RESULTS WERE VALID AND REPORTED THE RESULTS. THE CUSTOMER RETURNED THE SUSPECT CALIBRATORS FOR INVESTIGATION. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA IGG ANTIBODY MEIA FOR THE MEASUREMENT OF IGM ANTIBODIES TO RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 60943M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM RUBELLA CALIBRATORS: LOT# 60258M100| AXSYM RUBELLA CALIBRATORS: LOT# 58184M100| LOT# 58186M100| AXSYM RUBELLA CONTROLS:| AXSYM ANALYZER