BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061568 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00090
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 1, 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
    UT, 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 REPORTING CALIBRATION FAILURES FOR THE AXSYM RUBELLA IGG ASSAY, HOWEVER, DOES NOT HAVE THE SAME ISSUE WITH OTHER AXSYM ASSAYS. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) ASSISTED THE CUSTOMER IN TROUBLESHOOTING PROCEDURES AND DETERMINED THE CUSTOMER WAS UTILIZING THE BULK MUP REAGENT BEYOND 14 DAYS ON-BOARD RECOMMENDATION. IN THE CUSTOMER'S ATTEMPT TO TROUBLESHOOT THE ISSUE, A SUCCESSFUL CALIBRATION WAS ACHIEVED USING THE RUBELLA SPECIMEN DILUENT INSTEAD OF THE CALIBRATOR A. THE CTA ADVISED THE CUSTOMER THE CALIBRATION WAS UNACCEPTABLE WHEN USING SPECIMEN DILUENT IN PLACE OF CALIBRATOR A, AND WAS SENT NEW CALIBRATORS AND REAGENT. UPON RECEIPT OF THE NEW CALIBRATORS AND REAGENT, RECALIBRATION WAS UNSUCCESSFUL. THE CUSTOMER USED A DIFFERENT COMBINATION OF REAGENT AND CALIBRATORS AND ACHIEVED A SUCCESSFUL RUBELLA CALIBRATION. THE CUSTOMER AGREED TO RETURN SUSPECT REAGENTS AND CALIBRATORS FOR INVESTIGATION. 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 IGG ANTIBODY MEIA FOR THE MEASUREMENT OF IGM ANTIBODIES TO RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 60943M100

    Patients

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