BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1152663 · Received September 10, 2008

    Report

    Report Number
    1415939-2008-00261
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 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
    AS
    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 STATED THAT, THEY HAD PROBLEMS TRYING TO CALIBRATE RUBELLA ON THE AXSYM ANALYZER. THE CALBRATORS WERE NEAR THE EXPIRATION DATE AND WERE FAILING WITH ERRORS RELATED TO PRECISION SUCH AS RANGE TOO LARGE AND CAL A/B RATIO TOO LARGE. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) ASKED THE CUSTOMER TO REPLACE AND CALIBRATE THE SAMPLE PIPETTOR AND TO DECONTAMINATE LINE 1 AND REPLACE SOLUTION 1 WITH A NEW BOTTLE. THE CUSTOMER PERFORMED THE RECOMMENDED ACTIONS WITHOUT RESOLUTION. THE ABBOTT FIELD SERVICE TECHNICIAN CHECKED THE PUMPS FOR LEAKS OR DAMAGE, REPLACED THE SYRINGE AND PUMP VALVES AND PERFORMED TUBING DECONTAMINATION. A RECALIBRATION WAS PERFORMED AND FAILED AGAIN. THE CTA ASKED THE CUSTOMER TO CENTRIFUGE THE CALIBRATOR AND THEN RECALIBRATE USING THE SUPERNATANT. THE CALIBRATION PASSED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER