BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061585 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00104
    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
    NY, 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 SUPPORT SPECIALIST (TSS) REPORTED TWO UNSUCCESSFUL CALIBRATION OF THE AXSYM RUBELLA IGG ASSAY WHEN INTEGRATING THE RUBELLA ASSAY AT THE CUSTOMER FACILITY. THE TSS OBSERVED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A, RESULT TOO HIGH), THEREFORE, ABBOTT SENT THE TSS NEW REAGENTS AND CALIBRATORS. THE TSS REPORTED NO CALIBRATION ISSUES WITH OTHER AXSYM ASSAYS. THE TSS ATTEMPTED RECALIBRATION WITH THE NEW LOT OF REAGENT WITH THE CURRENT AND NEW CALIBRATOR MATERIAL AND OBSERVED THE SAME ERROR CODE. ABBOTT SENT NEW CALIBRATOR AND REAGENT MATERIAL AND A SUCCESSFUL CALIBRATION WAS ACHIEVED AND THE ISSUE WAS RESOLVED. THE SUSPECT REAGENTS AND CALIBRATORS WERE RETURNED FOR INVESTIGATION PURPOSES. 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 58296M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM RUBELLA CALIBRATORS: LIST# 09C29-01| AXSYM ANALYZER: LIST# 07A83-95| LIST# 03B23-20| LOT# 61236M200 AND 62167M200| AXSYM RUBELLA CALIBRATORS: LIST# 09C29-01| LOT# 58184M100| AXSYM RUBELLA REAGENT: