BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2923567 · Received January 22, 2013

    Report

    Report Number
    2122870-2013-00045
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, THE FIELD SERVICE ENGINEER (FSE) REMOVED THE ANALYTICAL MODULE AND REPLACED THE MIXER BEARINGS AND MIXER BELT. THE FSE CLEANED THE WASH AND PRECISION VALVES AND NOTED THE INCUBATOR BELT AND TRACK WERE CLEAN. THE FSE PERFORMED ULTRASONIC VOLTAGES AND NECESSARY ALIGNMENTS AND COMPLETED ROUTINE SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. NOTE: THE CUSTOMER'S BIO-MEDICAL ENGINEER HAD COMPLETED PREVENTIVE MAINTENANCE (PM) ON (B)(6) 2012 AND REPLACED THE ASPIRATE PROBES. THE PATIENT SAMPLES WERE COLLECTED IN 4-5 ML GREEN TOP LITHIUM HEPARIN TUBE AT CENTRIFUGED AT 3,200 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES. THE CUSTOMER STATED THE LABORATORY DOES NOT TEST ICTERIC OR HEMOLYZED SAMPLES, AND THE SAMPLE QUALITY WAS GOOD. QUALITY CONTROL (QC) IS TESTED EVERY 24 HOURS AND WAS WITHIN SPECIFICATION ON THE DAY OF THE EVENT. SYSTEM CHECK, PERFORMED ON (B)(6) 2012, PASSED WITHIN SYSTEM SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TROPONIN I (ACCESS ACCUTNI) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT SAMPLE PRODUCED AN INITIAL RESULT OF 4.597 NG/ML. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AT 17:28 HOURS AND REANALYZED TWICE ON AN ALTERNATE ACCESS 2 SYSTEM AND RECOVERED LOWER RESULTS OF 0.011 AND 0.009 NG/ML, WITHIN THE NORMAL REFERENCE RANGE. A THIRD SAMPLE WAS COLLECTED FROM THE PATIENT AT 21:27 HOURS AND REANALYZED TWICE ON THE ALTERNATE ACCESS 2 SYSTEM AND RECOVERED LOWER RESULTS OF 0.013 AND 0.013 NG/ML, ALSO WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE ERRONEOUS RESULT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29172 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1