BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2582281 · Received May 21, 2012

    Report

    Report Number
    2122870-2012-01348
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE ACCESS 2 IMMUNOASSAY SYSTEM (ACCESS 2) GENERATED AN ERRONEOUS TROPONIN I (ACCUTNI) PATIENT RESULT. CUSTOMER REPORTED THAT ACCESS ACCUTNI REAGENT, LOT 122054, AND ACCESS ACCUTNI CALIBRATORS (S0-S5), LOT 121451, WERE USED IN CONJUNCTION WITH THE ACCESS 2 ANALYZER. CUSTOMER REPORTED THAT THE SAMPLE WAS FROM A PATIENT WHO WAS INITIALLY PRESENTED TO THE EMERGENCY DEPARTMENT (ED). CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK. THE FSE FOUND ALL THE PARAMETERS WERE PASSING WITHIN SPECIFICATIONS. THE FSE VERIFIED THE SAMPLE HANDLING AND INSTRUMENT MAINTENANCE WERE ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1