BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2960098 · Received February 13, 2013

    Report

    Report Number
    2122870-2013-00108
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE VACUUM PUMP DUE TO LEAKING AND NOT MAINTAINING PRESSURE WHEN THE UNIT WAS TURNED OFF. THE FSE PERFORMED A MINOR PREVENTATIVE MAINTENANCE (PM-C) AND REPLACED THE INCUBATOR PULLEY, INCUBATOR BELT, MIXER PULLEYS, AND PINCH ROLLERS. SYSTEM VERIFICATION TESTING (HIGH SENSITIVITY SYSTEM CHECK, SYSTEM CHECK, PRECISION TESTING, AND QC) WAS PERFORMED AND WITHIN THE ASSAY AND SYSTEM SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00109.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION AND ABOVE THE NORMAL REFERENCE RANGE, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT ANALYSIS OF THE PATIENTS' SAMPLES, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE AND WITHIN THE RISK STRATIFICATION. THE CUSTOMER STATED TWO OF THE ERRONEOUS REPORTS WERE RELEASED OUT OF THE LABORATORY AND AMENDED REPORTS WERE ISSUED. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPEATED ALL PATIENT SAMPLES IN QUESTION BACK TO THE LAST ACCEPTABLE QUALITY CONTROL (QC). ALL LEVELS OF QC WERE PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT ONE OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63508 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1