BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2821837 · Received November 6, 2012

    Report

    Report Number
    2122870-2012-01869
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A ROUTINE SYSTEM PERFORMANCE WHICH FAILED, WITH AN INCREASE OF COEFFICIENT OF VARIATION (CV) (18.59%) OF THE WASHED PORTION (INSTRUMENT SPECIFICATIONS: 0.00%-12.00%). THE FSE NOTED THE ASPIRATE PROBES WERE NOT DEFLECTING BACK INTO POSITION AFTER ASPIRATION DUE TO A STICKY WHITE SUBSTANCE ON THE TWIST LOCK AND IN BETWEEN THE PROBES AND LOCK. THIS RESULTED IN THE ASPIRATE PROBES NOT REACHING THE BOTTOM OF THE REACTION VESSEL (RV) LEADING TO POOR WASHING AND INCOMPLETE ASPIRATION OF THE UNBOUND ANALYTE. THE FSE PERFORMED A PREVENTATIVE MAINTENANCE MAJOR (PM-A), REPLACED ALL ASPIRATE PROBES AS A PART OF THE PM-A, PERFORMED A PASSING SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, CALIBRATION, AND 20-REPETITION PRECISION TESTING USING WASH BUFFER AND LEVEL 1 QUALITY CONTROL (QC) AS SAMPLES; ALL RESULTS WERE WITHIN THE ASSAY AND LABORATORY SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER THE ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2012-01865, 2122870-2012-01866, 2122870-2012-01867, 2122870-2012-01868, 2122870-2012-01869.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, FOR MULTIPLE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED ALL PATIENT RESULTS WERE AUTO VERIFIED. THE ERRONEOUS RESULTS WERE RELEASED FROM THE LABORATORY AND RANGED FROM 0.3 NG/ML TO 0.4 NG/ML FOR ALL PATIENTS. THE PATIENT SAMPLES WERE REANALYZED ON AN ALTERNATE ACCESS 2 SYSTEM AFTER THE PHYSICIAN QUESTIONED ONE OF THE RESULTS; RETEST RESULTS RECOVERED IN THE NEGATIVE RANGE. ONE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE ERRONEOUS RESULT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER INDICATED THERE WERE NO HARDWARE OR ASSAY ISSUES. SYSTEM CHECK, PERFORMED ON (B)(6) 2012, PASSED WITHIN SPECIFICATION. QUALITY CONTROL (QC) IS PERFORMED DAILY AND HAD PASSED ON THE DAY OF THE EVENT. PATIENT SAMPLES WERE COLLECTED IN LITHIUM HEPARIN SAMPLE TUBES AND CENTRIFUGED IN A STAT CENTRIFUGE FOR THREE MINUTES. ALL SAMPLES ARE ANALYZED WITHIN 30 MINUTES OF COLLECTION. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization