BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061587 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00102
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 7, 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
    MN, 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 ABBOTT TECHNICAL SPECIALIST (TS) REPORTED THE INABILITY TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY AND OBSERVED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A RATE TOO LARGE). THE TS STATED ALL OTHER AXSYM ASSAYS WERE CALIBRATED SUCCESSFULLY EXCEPT RUBELLA. THE CUSTOMER WAS SENT NEW LOTS OF REAGENT AND CALIBRATORS FOR TROUBLESHOOTING. UPON RECEIPT OF THE NEW REAGENT AND CALIBRATORS THE TS ACHIEVED SUCCESSFUL CALIBRATION AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PT MANAGEMENT.

    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 60943M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM RUBELLA CALIBRATORS: LIST# 09C29-01| AXSYM ANALYZER: LIST# 07A83-95| LOT# 58184M100