BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1152863 · Received September 10, 2008

    Report

    Report Number
    1628664-2008-00302
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    February 14, 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
    FR
    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 REGARDING FAILED CALIBRATIONS FOR THE AXSYM RUBELLA IGG ASSAY, WHERE ERROR CODE 1111 (CALIBRATION CHECK FAILURE, M-CAL 1, RESPONSE TOO LARGE) WAS GENERATED. THE CUSTOMER WAS ASKED TO CHECK THE VOLUME OF BULK SOLUTION DISPENSERS, CENTRIFUGE THE CALIBRATORS AND RECALIBRATE THE RUBELLA ASSAY. THE CUSTOMER CALLED BACK TO REPORT THE RECALIBRATION WAS UNSUCCESSFUL AND THE SAME ERROR MESSAGE WAS GENERATED. THERE WAS NO IMPACT TO PT MGMT 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 ANTIBOFY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM RUBELLA MASTER CALIBRATORS| LOT#57959M100| AXSYM ANALYZER