BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061597 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00099
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 6, 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
    PA, 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 THEY WERE UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY AFTER TWO ATTEMPTS. THE CUSTOMER STATED WEEKLY MAINTENANCE WAS PERFORMED, REPLACED BOTH PROBES AND FLUSHED THE ANALYZER. THE CUSTOMER ATTEMPTED A RECALIBRATION WHICH FAILED. THE CUSTOMER STATED THERE IS NO CALIBRATION ISSUE WITH OTHER AXSYM ASSAYS. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) REVIEWED TROUBLESHOOTING PROCEDURES AND CALIBRATION DATA, AND SENT THE CUSTOMER A NEW LOT OF REAGENT. AS PART OF THE TROUBLESHOOTING, THE CTA REQUESTED THE CUSTOMER SPIN RUBELLA CALIBRATOR A AND ATTEMPT RECALIBRATION, WHICH WAS UNSUCCESSFUL. THE CUSTOMER WAS SENT A NEW LOT OF CALIBRATORS FOR TROUBLESHOOTING AND THE CALIBRATOR A VALUES WERE ELEVATED. THE CUSTOMER USED A DIFFERENT LOT OF CALIBRATOR AND WAS ABLE TO ACHIEVE SUCCESSFUL CALIBRATION. THE CTA REQUESTED THE CUSTOMER RETURN THE SUSPECT CALIBRATORS 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 IGG ANTIBODY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 58295M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention AXSYM RUBELLA CALIBRATORS: LIST#09C29-01| LOT#61236M200| AXSYM RUBELLA CALIBRATORS: LIST#09C29-01| LOT# 62167M200| AXSYM ANALYZER: LIST # 07A83-95| LOT#58184M100