BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2242308 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03335
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK. THE SYSTEM CHECK PASSED. THE FSE OBSERVED THAT THE SYSTEM CHECK SUBSTRATE RATIO FAILED. THE FSE RESOLVED THE FAILURE BY CLEANING THE ASPIRATE PROBES. THE FSE VERIFIED THAT SYSTEM RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE, A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT DISCREPANT RESULTS FOR TROPONIN I (ACCUTNI) FOR TWO (2) PATIENT SAMPLES ASSAYED USING ACCESS ACCUTNI REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. FOR ONE OF THE PATIENT SAMPLES, THE INITIAL ACCUTNI RESULT WAS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF CONCENTRATION. UPON REPEAT ANALYSIS, THE PATIENT SAMPLE RECOVERED LOWER AND WITHIN THE RISK STRATIFICATION RANGE. FOR THE OTHER PATIENT SAMPLE, THE INITIAL ACCUTNI RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. UPON REPEAT ANALYSIS, THE PATIENT SAMPLE RECOVERED HIGHER AND WITHIN THE RISK STRATIFICATION RANGE. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS HAD BEEN RECOVERING WITHIN THE LABORATORY'S ESTABLISHED RANGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI REAGENT