BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061570 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00088
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    April 19, 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
    MI, 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 THE INABILITY TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY FOLLOWING WEEKLY AND MONTHLY MAINTENANCE. THE CUSTOMER STATED RUBELLA CALIBRATION WAS UNSUCCESSFUL AFTER FIVE ATTEMPTS, HOWEVER, THERE WAS NO ISSUE WITH CALIBRATION OF OTHER AXSYM ASSAYS. THE CUSTOMER WAS SENT NEW MASTER CALIBRATORS AND REAGENTS. THE CUSTOMER REPORTED CALIBRATION WAS UNSUCCESSFUL WITH REPLACEMENT REAGENTS AND CALIBRATORS AND WAS ASKED TO RETURN THE REPLACEMENT MATERIAL FOR INVESTIGATION. THE CUSTOMER REQUESTED RUBELLA STANDARD CALIBRATORS AND A DIFFERENT LOT OF REAGENT. UPON RECEIPT OF THE NEW MATERIAL, THE CUSTOMER ATTEMPTED RECALIBRATION AND OBTAINED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CAL A RESULT TOO HIGH). THE CUSTOMER REPORTED A SUCCESSFUL CALIBRATION WAS OBTAINED WITH A DIFFERENT COMBINATION OF REAGENT AND CALIBRATORS AND THE ISSUE WAS RESOLVED. 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 IGM ANTIBODIES TO RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 57577M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM RUBELLA MASTER CALIBRATORS| AXSYM PLUS ANALYZER| LOT# 60003M100