BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1152625 · Received September 10, 2008

    Report

    Report Number
    1415939-2008-00252
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    November 1, 2007
    Report Date
    November 1, 2007
    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 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 IS UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG REAGENT, USING REAGENT LOT # 52254M204. ERROR CODE 1048 (A/B RATIO TOO HIGH) WAS GENERATED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT 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 52254M201

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER