BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2183542 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-01137
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THIS EVENT. ONCE THE ERRONEOUS RESULTS WERE DISCOVERED THE OPERATOR RAN A DIAGNOSTIC SYSTEM CHECK WHICH WAS WITHIN SPECIFICATIONS. H3: FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER (B)(4) 2008. THE PIPETTOR WAS LOOSE, THE MIXER SPEED WAS OUT OF SPECIFICATION LOW, AND THE PRECISION PUMP MOUNTING SCREW WAS DISCONNECTED. THE FSE ADJUSTED THE ULTRASONICS AND REPLACED THE PRECISION PUMP BELT. A PRECISION RUN AND QUALITY CONTROL MET SPECIFICATIONS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED SPECIFICATIONS. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS WERE OBTAINED WHEN USING AN ACCESS 2 IMMUNOASSAY SYSTEM. FOUR PATIENT SAMPLES WERE TESTED FOR VITAMIN B12 AND FREE T4 AND ERRONEOUS ELEVATED TEST RESULTS WERE OBTAINED. AN INSTRUMENT MESSAGE DID OCCUR WITH TWO OF THE FOUR TESTS. ALL TESTS WERE REPEATED, AND WERE WITHIN THE NORMAL REFERENCE RANGE. NO ERRONEOUS TEST RESULTS WERE REPORTED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM CGN BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS FREE T4 ASSAY| ACCESS VITAMIN B12 ASSAY