BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1063614 · Received June 19, 2008

    Report

    Report Number
    1415939-2008-00140
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    March 25, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-06/06/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    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 STATED THE RUBELLA CALIBRATION FAILED ON THE AXSYM ANALYZER WITH ERROR CODE 1111: CAL 1 TOO HIGH. THE ABBOTT CUSTOMER SERVICE TECHNICIAN (CTA) INSTRUCTED THE CUSTOMER PERFORM A MEAI CHECK, DECONTAMINATE THE MUP, REPLACE THE PROBES AND RERUN THE CALIBRATION. THE CTA ALSO SENT THE CUSTOMER REPLACEMENT REAGENT AND CALIBRATOR. AFTER PERFORMING THE MAINTENANCE AND RECEIVING AND USING THE NEW CALIBRATOR AND REAGENT, THE CALIBRATION STILL FAILED. THE CUSTOMER WAS ABLE TO ACHIEVE A PASSING CALIBRATION BY RUNNING THE CALIBRATION SEVERAL TIMES. NO IMPACT TO PT MANAGEMENT WAS 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 56659M201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI RUBELLA CAL LIST# 9C29-01| AXSYM ANALYZER