BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1063622 · Received June 19, 2008

    Report

    Report Number
    1415939-2008-00137
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    March 21, 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 THAT THE RUBELLA CALIBRATION FAILED ON THE AXSYM ANALYZER DUE TO THE RATIO A/B BEING TOO HIGH. THE CUSTOMER DECONTAMINATED LINES 3 AND 4 WITH NEW SOLUTION AND CHECKED THE VOLUME OF THE DISPENSERS. THE ABBOTT CUSTOMER SERVICE TECHNICIAN (CTA) ADVISED THE CUSTOMER TO CLEAN THE MEIA OPTICS LINE BESIDE THE MATRIX CAROUSEL, DECONTAMINATE LINE 1 WITH NEW MUP, PERFORM A MEIA CHECK, AND REPLACE THE MATRIX CELLS. ALL THE MAINTENANCE WAS PERFORMED WITHOUT RESOLUTION. THE CTA ORDERED 6-POINT CALIBRATORS FOR THE CUSTOMER AND SUGGESTED REPLACING THE PROBES. A FOLLOW-UP WITH THE CUSTOMER CONFIRMED THE RECEIPT OF THE CALIBRATORS; HOWEVER, THE CUSTOMER CENTRIFUGED THE OLD CALIBRATORS AND THE CALIBRATION PASSED. 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 56323M101

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM ANALYZER| RUBELLA MCAL LIST# 3A23-30