BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1964406 · Received January 19, 2011

    Report

    Report Number
    2122870-2011-00069
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND THE RESULTS WERE WITHIN THE SPECIFICATIONS. THE CUSTOMER WAS GETTING INTERMITTENT LOW VACUUM ERRORS AT THE TIME OF THIS EVENT. SERVICE WAS ON SITE ON (B)(4) 2010 AND WAS ABLE TO DUPLICATE THE VACUUM ERRORS. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE VACUUM VALVE, VACUUM PUMP, AND THE VACUUM BOTTLE. THE FSE PERFORMED A PREVENTIVE MAINTENANCE. ALL VERIFICATION TEST RESULTS MET THE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE AMI CUTOFF GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT WAS GIVEN LOVENOX DUE TO THE ERRONEOUSLY ELEVATED ACCUTNI RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other