BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1063618 · Received June 19, 2008

    Report

    Report Number
    1415939-2008-00135
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    March 18, 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
    FR
    Reporter Occupation
    UNKNOWN

    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 RUBELLA CALIBRATION FAILED SEVERAL TIMES ON THE AXSYM ANALYZER WITH ERROR CODE 1048: CALIBRATION FAILURE, CAL A/B RATIO TOO LARGE. THE CUSTOMER REPLACED THE MATRIX CELL LOT, REPLACE AND CALIBRATED THE PROBES, DECONTAMINATED THE MUP LINE AND REPLACED THE MUP WITHOUT RESOLUTION. THE ABBOTT CUSTOMER SERVICE TECH (CTA) ADVISED THE CUSTOMER TO CLEAN THE MEIA OPTIC LINE AT THE MATRIX CAROUSEL AND DECONTAMINATE 3 AND 4 FOLLOWED BY A RECALIBRATION. THE CUSTOMER TRIED A NEW LOT OF RUBELLA REAGENT AND CALIBRATORS WITHOUT RESOLUTION. AFTER COMPLETING ALL THE MAINTENANCE, THE CUSTOMER HAD TO REPEAT THE CALIBRATION SEVERAL TIMES TO OBTAIN A PASSING CALIBRATION. NO IMPACT TO PT 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 56659M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI RUBELLA MCAL| AXSYM ANALYZER