BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1152644 · Received September 10, 2008

    Report

    Report Number
    1415939-2008-00256
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 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
    AS
    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 STATED THAT, THE AXSYM RUBELLA IGG REAGENT FAILED TO CALIBRATE WITH ERROR CODE 1018: CALIBRATION CHECK FAILURE, CAL A, RESULTS TOO HIGH, ON THE AXSYM ANALYZER. THE CUSTOMER STATED THEY WERE WASTING A SIGNIFICANT AMOUNT OF MATERAIL WITH INCREASED EXPENSE TRYING TO GET THE ASSAY CALIBRATED. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE ASKED THE CUSTOMER TO TRY CALIBRATING WITH THE STANDARD CALIBRATOR AGAIN AND USING CAL A THAT HAS BEEN CENTRIFUGED. THE CTA ADVISED THE CUSTOMER THAT THE CAL A MATERIAL IS DETERIORATING AND SHEDDING PROTEIN AGGREGATES OVER TIME. A FOLLOW-UP WITH THE CUSTOMER CONFIRMED THE RUBELLA ASSAY HAD CALIBRATED WHEN USING THE CENTRIFUGED MATERIAL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    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 57577M200

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER