BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA LGG ANTIBODY

    MDR report key: 1341445 · Received March 12, 2009

    Report

    Report Number
    1415939-2008-00281
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Date of Event
    January 14, 2008
    Report Date
    January 15, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GOL
    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

    (NO CONSEQUENCE OR IMPACT TO PATIENT). (CALIBRATION ERROR). (ERROR MESSAGE GIVEN) 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 REPORTED FAILED CALIBRATION WITH THE ABBOTT AXSYM RUBELLA LGG ASSAY, AS CALIBRATOR A WAS TOO HIGH. THE CUSTOMER WAS ABLE TO SUCCESSFULLY RECALIBRATE USING BULK SOLUTION 3 INSTEAD OF THE RUBELLA CALIBRATOR A. THE CUSTOMER WAS SENT RUBELLA CALIBRATORS AND CONTROLS AND UPON RECALIBRATION WITH THE NEW CALIBRATORS, A SUCCESSFUL RUBELLA LGG CALIBRATION WAS ACHIEVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA LGG ANTIBODY MEIA FOR THE MEASUREMENT OF LGG ANTIBODY TO THE RUBELLA VIRUS GOL ABBOTT LABORATORIES NA 55922M100

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM RUBELLA MASTER CALIBRATORS| AXSYM ANALYZER| LOT# 53795M100