BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA LGG ANTIBODY

    MDR report key: 1341461 · Received March 12, 2009

    Report

    Report Number
    1415939-2008-00275
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Date of Event
    November 9, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GOL
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-6/06/08-004-C
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 OBSERVED AXSYM CALIBRATION ERROR CODE 1018 ( CALIBRATION CHECK FAILURE, CALIBRATOR A, RESULT TOO HIGH) FOR THE AXSYM RUBELLA LGG ASSAY. THE CUSTOMER ATTEMPTED TO CALIBRATE THE RUBELLA ASSAY SIX TIMES WITHOUT SUCCESS AND WAS SENT A NEW LOT OF RUBELLA LGG CALIBRATOR, AND THE ISSUE WAS RESOLVED. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS AT THE CUSTOMER SITE AND THE SUSPECT REAGENTS WERE TESTED AT ANOTHER CUSOTMER SITE AND WERE DETERMINED NOT TO BE THE CAUSE OF THE ISSUE. IN TROUBLESHOOTING THE ISSUE, THE CUSTOMER ASSAYED THE CALIBRATORS FROM A PREVIOUSLY STORED CALIBRATIOIN CURVE, THEN REPLACED CALIBRATOR A WITH THE RUBELLA NEGATIVE CONTROL AND ACHIEVED A SUCCESSFUL CALIBRATION. THE CUSTOMER WAS SENT NEW RUBELLA CALIBRATORS AND THE CALIBRATION FAILED AGAIN. THE CUSTOMER SENT THE REAGENTS TO ANOTHER CUSTOMER SITE FOR TESTING AND CALIBRATOIN WAS ACCEPTED. THE FSR REPLACED THE OPTICAL STANDARD, RECALIBRATED THE OPTICS, CHECKED THE BULK MUP AND THE MATRIX CAROUSEL. UPON COMPLETION OF THE TROUBLESHOOTING PROCEDURES, A SUCCESSFUL RUBELLA CALIBRATION WAS ACHIEVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# 53841M100| AXSYM RUBELLA CALIBRATORS| AXSYM ANALYZER