BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2183585 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-02166
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    February 17, 2009
    Report Date
    February 17, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2009 AT 09:40, PASSED WITHIN SPECIFICATIONS. QUALITY CONTROL (QC) LEVELS 1 AND 2 WERE OUT OF SPECIFICATION HIGH AT 11:40, PRIOR TO THE ERRONEOUS RESULTS. THE CUSTOMER REPEATED THE QC AND IT WAS STILL OUT OF SPECIFICATION HIGH. CUSTOMER WAS ADVISED BY CUSTOMER SUPPORT HOTLINE TO PERFORM WEEKLY MAINTENANCE, RECALIBRATE AND REPEAT QC THE MORNING OF (B)(4) 2009. ALL THREE LEVELS OF QC WERE WITHIN SPECIFICATIONS AFTER MAINTENANCE AND RECALIBRATING. CUSTOMER THEN REPEATED PATIENT SAMPLES AND STILL OBSERVED PRECISION ISSUES WITH B12. CUSTOMER NOTED PRECISION ISSUES WITH OTHER B12 PATIENT SAMPLES ALSO. THE FOUR PATIENT SAMPLES, WERE THE ONLY SAMPLES THAT RESULTED IN DIFFERENT CLINICAL CATEGORIES. CUSTOMER ONLY HAS ONE ACCESS SYSTEM INSTRUMENT WHICH WOULD RULE OUT PACK SHARING. FIELD SERVICE ENGINEER PERFORMED HARDWARE VERIFICATION TESTING AND ALL MET PUBLISHED PERFORMANCE SPECIFICATIONS. NO DEFICIENCIES WERE IDENTIFIED. ROOT CAUSE IS UNKNOWN. 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 VITAMIN B12 TEST RESULTS WERE OBTAINED WHEN USING AN ACCESS 2 IMMUNOASSAY SYSTEM. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. 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 VITAMIN B12 ASSAY| CALIBRATORS