BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3253403 · Received July 29, 2013

    Report

    Report Number
    2122870-2013-00650
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED A LOOSE PRECISION PUMP MOUNTING SCREW AND EVIDENCE OF DRIED WASH BUFFER IN THE WASH CAROUSEL. THERE WERE NO BUBBLES IN THE WASH OR PRECISION PUMP AND ALL FITTINGS WERE SECURED. THE FSE PERFORMED A MAJOR PREVENTATIVE MAINTENANCE (PM). ALL VERIFICATION STUDIES PASSED. THE FSE PERFORMED A PRECISION TEST AND CONCLUDED SERVICE. 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. THE LIKELY CAUSE OF THE REPORTED ISSUE WAS A LOOSE PRECISION PUMP MOUNTING SCREW. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00647, 2122870-2013-00648, 2122870-2013-00649, 2122870-2013-00650, 2122870-2013-00651.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR MULTIPLE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. INITIAL RESULTS OF 0.04 NG/ML AND 0.10 NG/ML WERE OBTAINED FOR TWO PATIENTS. SUBSEQUENT ANALYSES OF THE PATIENTS¿ SAMPLES, ON THE SAME INSTRUMENT, RECOVERED LOWER RESULTS OF 0.03 NG/ML FOR THE FIRST PATIENT AND 0.02 NG/ML AND 0.04 NG/ML FOR THE SECOND PATIENT. THE ORIGINAL RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DEFINES CRITICAL RESULTS AS ANY VALUE GREATER THAN 0.03 NG/ML WITH A CUTOFF VALUE OF 0.04 NG/ML. REPEAT TESTING IS PERFORMED PRIOR TO THE RESULT IS RELEASED FROM THE LABORATORY. THE CUSTOMER STATED RECENT SYSTEM CHECK PASSED WITHIN SPECIFICATIONS AND NO QUALITY CONTROL (QC) ISSUES WERE NOTED. THE PATIENTS¿ SAMPLES WERE COLLECTED IN LITHIUM HEPARIN GEL TUBE AND CENTRIFUGED AT 7,200 RPM (ROTATIONS PER MINUTE) IN A STAT SPIN CENTRIFUGE FOR THREE MINUTES. THE ORIGINAL SAMPLES WERE ANALYZED FROM THE PRIMARY TUBES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT FOUR OF FIVE REFERENCING THE TWO PATIENTS ON THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354173 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1