BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1063504 · Received June 19, 2008

    Report

    Report Number
    1415939-2008-00132
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    March 14, 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
    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 WITH ERROR CODE 1048: CALIBRATION CHECK FAILURE, CAL A/B RATIO TOO HIGH, ON THE AXSYM ANALYZER. THE ABBOTT CUSTOMER SERVICE TECHNICIAN (CTA) INSTRUCTED THE CUSTOMER TO CHECK THE DISPENSER RINSE VOLUME, AND DECONTAMINATE LINES 1, 3, AND MUP. THE CTA SENT THE CUSTOMER STANDARD CALIBRATOR. UPON RECEIPT OF THE STANDARD CALIBRATOR, THE CUSTOMER RECALIBRATED AND RECEIVED ANOTHER FAILED CALIBRATION WITH AN ERROR. THE CTA HAD THE CUSTOMER PERFORM THE MAINTENANCE AGAIN, REPLACE THE PROCESS PROBE, AND LET THE CALIBRATOR SIT, FOLLOWED BY ANOTHER CALIBRATION. THE CALIBRATION PASSED. THE CUSTOMER REQUESTED REPLACEMENT RUBELLA REAGENT DUE TO THE MULTIPLE TESTS USED TO CALIBRATE. NO IMPACT TO PATIENT 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 56323M101

    Patients

    Seq Age Sex Outcome Treatment
    1 NI RUBELLA MCAL: LOT# 57959M100| AXSYM ANALYZER