BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2821566 · Received November 6, 2012

    Report

    Report Number
    2122870-2012-01874
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, WERE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS. TESTING BY AN ALTERNATE METHODOLOGY PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. REPEAT TESTING ON THE ORIGINAL ACCESS 2 INSTRUMENT PRODUCED RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR TWO PATIENTS AND A RESULT WITHIN THE NORMAL REFERENCE RANGE FOR ONE PATIENT. THE CUSTOMER INDICATED THE INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THEREFORE THERE WAS NO IMPACT ON THE PATIENT TREATMENT. THE SAMPLES WERE COLLECTED IN BECKTON DICKINSON 3 ML LITHIUM HEPARIN PLASMA SEPARATOR TUBES AND WERE CENTRIFUGED AT 3500 RPM FOR 5 MINUTES AT ROOM TEMPERATURE. THE CUSTOMER REPORTED THAT THE SAMPLES WERE NOT LOW VOLUME, ICTERIC, HEMOLYZED, OR LIPEMIC. REVIEW OF THE QC DATA INDICATED THAT THE QC RESULTS WERE OUT OF THE ESTABLISHED RANGES ON THE DAY OF THE EVENT. THE SUPPLIED ACCUTNI CALIBRATION CURVE FROM (B)(6) 2012 SHOWS ALL LEVELS OF CALIBRATORS PASSING WITH ACCEPTABLE %CVS. ROUTINE SYSTEM CHECKS, PERFORMED ON (B)(6) 2012, WERE PASSING WITHIN INSTRUMENT SPECIFICATIONS. BEC FIELD SERVICE ENGINEER (FSE) NOTED AIR BUBBLES IN THE TUBING OF WASH PROBES #3 AND #5 AND REPLACED THE WASH PUMP SEAL TO RESOLVE THIS ISSUE. THESE AIR BUBBLES IN THE TUBING MAY LEAD TO THE IMPROPER AMOUNT OF WASH BUFFER BEING DISPENSED INTO THE REACTION VESSELS, WHICH MAY CAUSE INCOMPLETE WASHING OF THE UNBOUND ANALYTE. THE FSE VERIFIED SYSTEM PERFORMANCE BY RUNNING SYSTEM CHECK, QC, AND A 10 REPETITION PRECISION TEST.

    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. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1