BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061571 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00087
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    April 15, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-6/6/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS ON GOING. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED ABBOTT TO REPORT THREE UNSUCCESSFUL ATTEMPTS TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY WITH A NEW LOT OF REAGENT AND OBSERVED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A, RESULTS TOO HIGH). THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) REVIEWED THE CUSTOMER'S INSTRUMENT MESSAGE HISTORY AND DETERMINED MULTIPLE LEVEL SENSE ERRORS OCCURRED THE WEEK PRIOR TO THE ISSUE. THE CTA REQUESTED THE CUSTOMER PERFORM BULK SOLUTION VOLUME CHECKS AND OTHER TROUBLESHOOTING PROCEDURES, SPECIFICALLY, CHANGING THE SAMPLE PROBE. THE CUSTOMER REPORTED AFTER PERFORMING TROUBLESHOOTING PROCEDURES, CALIBRATION WAS UNSUCCESSFUL. THE CUSTOMER WAS SENT A NEW LOT OF RUBELLA REAGENT. THE ABBOTT FIELD SERVICE FSR WAS DISPATCHED TO THE SITE AND WAS NOT ABLE TO RESOLVE THE ISSUE. ADD'L LOTS OF CALIBRATORS WERE SENT TO THE CUSTOMER AND THE CUSTOMER WAS STILL UNABLE TO ACHIEVE SUCCESSFUL CALIBRATION AND REFUSED TO TROUBLESHOOT FURTHER. ALL REAGENTS AND CALIBRATORS WERE RETURNED 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 58295M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM RUBELLA CALIBRATORS| AXSYM ANALYZER| LOT# 60003M100| AXSYM RUBELLA MASTER CALIBRATORS| LOT 58184M100| AXSYM RUBELLA CALIBRATORS| LOT# 55912M100