BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA LGG ANTIBODY

    MDR report key: 1341438 · Received March 12, 2009

    Report

    Report Number
    1415939-2008-00292
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Date of Event
    February 1, 2008
    Report Date
    February 4, 2008
    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 CONTACTED ABBOTT REGARDING MASTER CALIBRATION ERROR CODE 1061 (MASTER CALIBRATION FAILURE, INCOMPLETE CALIBRATOR RESULTS) FOR THE AXSYM RUBELLA LGG ASSAY. THE CUSTOMER REPORTED THAT ANOTHER FAILED CALIBRATION OCCURRED IN 2008 WITH CALIBRATION DEVIATION TOO LARGE BETWEEN TWO POINTS. THE CUSTOMER WAS ADVISED TO REPLACE AND CALIBRATE THE SAMPLE PROBE AND ATTEMPT RECALIBRATION. THE CUSTOMER REPORTED RECALIBRATION FAILED AND ERROR CODE 1048 (CALIBRATION CHECK FAILURE, CAL A/B, RATIO TOO LARGE) WAS GENERATED. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE CALIBRATORS AND RECALIBRATE. RECALLIBRATION OF THE RUBELLA LGG ASSAY WAS SUCCESSFUL AFTER CALIBRATOR CENTRIFUGATION AND QUALITY CONTROLS WERE IN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

    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 56323M101

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM RUBELLA MASTER CALIBRATORS| LOT# 57959M100| AXSYM ANALYZER