BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3090848 · Received May 2, 2013

    Report

    Report Number
    2122870-2013-00421
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE TRANSDUCER AND PERFORMED ALIGNMENTS, AND THE ULTRASONICS VOLTAGES WERE SET TO INSTRUMENT SPECIFICATION. TO VERIFY PROPER SYSTEM OPERATION, THE FSE PERFORMED MULTIPLE PATIENTS PROGRAMING, TWO REPETITIONS OF TROPONIN I. NO FALSE HIGH RESULTS WERE NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00421, 2122870-2013-00422, 2122870-2013-00423.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR SEVEN PATIENTS, ON THREE SEPARATE DAYS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. THE CUSTOMER STATED EACH PATIENT'S SAMPLE PRODUCED DIFFERENT RESULTS AFTER ANALYZING THE SAMPLE SEVERAL TIMES ON THE ACCESS 2 SYSTEM. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLES, ON AN ALTERNATE METHODOLOGY, PRODUCED NEGATIVE RESULTS. THE CUSTOMER STATED THE SAMPLES WERE REPEATED DUE TO DELTA CHECK WITH PREVIOUS PATIENT RESULTS. THE ERRONEOUS PATIENT RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER CONTINUED TO ANALYZE PATIENT SAMPLES ON THE ALTERNATE METHODOLOGY. QUALITY CONTROL (QC) IS PERFORMED ONCE EVERY 24 HOURS. QUALITY CONTROL WAS WITHIN SPECIFICATION PRIOR TO THE EVENT; QC WAS NOT PERFORMED AFTER THE EVENT. THE PATIENTS' SAMPLES WERE COLLECTED BY THE EMERGENCY ROOM (ER) STAFF, IN THE ER. THE SAMPLES WERE COLLECTED IN 4.0 ML LITHIUM HEPARIN NON-GEL PLASMA TUBES AND CENTRIFUGED AT 3,600 RPM (ROTATIONS PER MINUTE) FOR SEVEN MINUTES FROM THE PRIMARY TUBES, AT ROOM TEMPERATURE. SAMPLES ARE STORED IN REFRIGERATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT ONE OF THREE REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192499 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR