BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1896226 · Received November 10, 2010

    Report

    Report Number
    2122870-2010-00734
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE PLASMA CENTRIFUGED AT 3,200 RPM FOR 7 MINUTES. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. THE WEEKLY MAINTENANCE AND A SYSTEM CHECK WERE PERFORMED ON (B)(6) 2010. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REVIEWED THE CUSTOMER'S SYSTEM CHECK AND DRY/WET TESTING; BOTH TESTS PASSED. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND PRECISION TEST USING ORIGINAL PATIENT SAMPLE; BOTH TESTS PASSED. NO HARDWARE ISSUES WERE NOTED. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUT OFF AND WITHIN THE RISK STRATIFICATION RANGE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR UNKNOWN NUMBER OF PATIENTS' SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. UPON REPEAT ON A DIFFERENT INSTRUMENT THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT NUMBER OF PATIENTS OR RESULTS FOR THIS EVENT. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1