BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2957152 · Received February 12, 2013

    Report

    Report Number
    2122870-2013-00074
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION THRESHOLD FOR ONE PATIENT. REPEAT TESTING ON THE SAME INSTRUMENT PRODUCED LOWER BUT ERRATIC RESULTS ABOVE AND WITHIN THE REFERENCE RANGE. THE CUSTOMER TESTED THE PATIENT SAMPLE BY AN ALTERNATE METHODOLOGY AND OBTAINED REPRODUCIBLE RESULTS WITHIN THE REFERENCE RANGE. ONLY ONE OF THE REPEAT RESULTS, WITHIN THE REFERENCE RANGE, WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION TO THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) NOTED THAT THE WASH VALVE ROTOR HAD A SLIGHT DEFORMATION ON THE ROTOR SHAFT, AND REPLACED THE ROTOR. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE BY RUNNING A PASSING HIGH SENSITIVITY SYSTEM CHECK. THE CUSTOMER USED THE BELOW REAGENT AND CALIBRATOR FOR TROPONIN ASSAY: ACCESS ACCUTNI REAGENT PACK, CATALOG NUMBER A78803, LOT NUMBER 225167 ACCESS ACCUTNI CALIBRATORS, CATALOG NUMBER 33345, LOT NUMBER 222575

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60314 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1