BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061566 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00091
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 2, 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
    CA, US
    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 TO REPORT THE INABILITY TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY AND OBTAINED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A, RESULTS TOO LOW), HOWEVER, REPORTED ALL OTHER ASSAYS WERE OKAY. THE CUSTOMER WAS SENT NEW REAGENTS AND CALIBRATORS AND UPON RECALIBRATION, OBTAINED THE SAME ERROR MESSAGE. THE CUSTOMER ALSO PERFORMED TROUBLESHOOTING PROCEDURES, INCLUDING ASSAYING CALIBRATOR A AS AN "UNKNOWN". THE CUSTOMER SUCCESSFULLY RECALIBRATED THE RUBELLA ASSAY WITH A DIFFERENT COMBINATION OF REAGENT AND CALIBRATORS, AND THE ISSUE WAS RESOLVED. THE CUSTOMER DID NO HAVE ANY REMAINING CALIBRATOR MATERIAL TO RETURN FOR INVESTIGATION PURPOSES. 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 58294M101

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT# 55912M100| AXSYM ANALZYER: LIST# 07A83-03| AXSYM RUBELLA CALIBRATORS: LIST# 09C29-01