BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061558 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00083
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    March 11, 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
    NJ, 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 MESSAGE 1018, (CALIBRATION CHECK FAILURE, CALIBRATOR A RESULT TOO HIGH). THE CUSTOMER ATTEMPTED TO RECALIBRATE AND OBTAINED THE SAME ERROR. THE CUSTOMER DID NOT PERFORM TROUBLESHOOTING, HOWEVER, STATED THERE WERE NO BUBBLES IN THE REAGENT PACK OR IN THE SAMPLE AND VERIFIED THE CALIBRATORS WERE IN THE CORRECT ORDER. THE ABBOT CUSTOMER TECHNICAL ADVOCATE (CTA) REVIEWED ADDITIONAL TROUBLESHOOTING PARAMETERS AND RECOMMENDED THE CUSTOMER CHANGE THE SAMPLE PROBE, PERFORM PROBE CALIBRATION AND RECALIBRATE THE RUBELLA ASSAY. WHEN THE ISSUE PERSISTED, THE CTA SENT A NEW LOT OF REAGENT AND CALIBRATORS TO THE CUSTOMER. THE CUSTOMER REPORTED A SUCCESSFUL CALIBRATION UPON RECEIPT OF THE NEW REAGENTS AND CALIBRATORS, AND RETURNED THE SUSPECT REAGENTS 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 57577M201

    Patients

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