BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3260618 · Received August 1, 2013

    Report

    Report Number
    2122870-2013-00665
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED AIR IN THE WASH PUMP AND REBUILT THE PRECISION AND WASH PUMPS BY REPLACING THE ROTOR, STATORS, AND CAPS ON EACH PUMP. SYSTEM VERIFICATION TESTING (SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, AND QUALITY CONTROL) WAS WITHIN INSTRUMENT AND LABORATORY SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION OR ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR THREE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING OF THE PATIENTS" SAMPLES, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED LOWER RESULTS; TWO WITHIN THE NORMAL REFERENCE RANGE AND ONE ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT. ALL THREE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENTS' SAMPLES WERE COLLECTED IN GREEN TOP 4 ML SODIUM HEPARIN TUBES AND CENTRIFUGED AT 8,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES. THE SAMPLES WERE PROCESSED IN 12X75 MM PLASTIC ALIQUOT TUBES. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THE CUSTOMER NOTED THE INSTRUMENT'S KEYBOARD AND MONITOR STOPPED FUNCTIONING. THE INSTRUMENT WAS NOT IN OPERATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360917 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1