BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1984345 · Received February 10, 2011

    Report

    Report Number
    2122870-2011-00377
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. AFTER THE ERRONEOUS RESULTS QC WAS OUT OF SPECIFICATIONS HIGH. PER THE CUSTOMER, PATIENT SAMPLES ANALYZED DURING THIS EVENT WERE REPEATED WITH REPRODUCIBLE RESULTS, EXCLUDING FIVE RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED MANY PARTS AND COMPLETED MANY ADJUSTMENTS. THE FSE ALSO PERFORMED VERIFICATION TESTS WHICH ALL MET SPECIFICATIONS. PER THE FSE, NOT ONE PARTICULAR HARDWARE ISSUE COULD BE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT AS HE REPLACED AND ADJUSTED SEVERAL COMPONENTS. ALTHOUGH HARDWARE IS A LIKELY CONTRIBUTING FACTOR, NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING CREATININE KINASE - MB (CK-MB) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR FOUR (4) PATIENTS' SAMPLES THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, UPON REPEAT TESTING THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLB BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1