BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1063605 · Received June 19, 2008

    Report

    Report Number
    1415939-2008-00158
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-06/06/08-0004-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 THE RUBELLA CALIBRATION FAILED WITH ERROR CODE 1048: CALIBRATION CHECK FAILURE, CAL A/B RATIO TOO HIGH, ON THE AXSYM ANALYZER. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) ASKED THE CUSTOMER TO REPLACE THE MATRIX CELL LOT, DECONTAMINATE THE MUP WITH NEW REAGENT, AND RECALIBRATE. THE CALIBRATION FAILED AGAIN. THE CTA ASKED THE CUSTOMER TO REPLACE THE PROCESS PROBE AND RECALIBRATE WHICH AGAIN RESULTED IN A FAILURE ERROR. THE CTA SENT THE CUSTOMER REPLACEMENT CALIBRATOR AND ASKED THE CUSTOMER TO CENTRIFUGE THE CALIBRATOR PRIOR TO USE. CENTRIFUGING RESULTED IN AN ACCEPTABLE CALIBRATION. 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 58295M101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA RUBELLA MCAL LIST# 3B23-30| AXSYM ANALYZER