BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 3388972 · Received October 4, 2013

    Report

    Report Number
    2122870-2013-00813
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON 09/16/2013. THE FSE EVALUATED THE INSTRUMENT AND ORDERED SEVERAL PARTS FOR A RETURN VISIT. THE FSE RETURNED TO THE CUSTOMER'S SITE ON (B)(4) 2013 TO COMPLETE THE NEEDED REPAIRS. THE FSE REPLACED THE MIXER ASSEMBLY, MIXER MOTOR, AND MIXER BELT TENSIONER TO RESOLVE THE ISSUE. THE FSE VERIFIED THE REPAIRS AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. RESULTS: FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE MIXER MOTOR AND MIXER BELT TENSIONER, WHICH CAUSED UNEVEN MIXING OF SAMPLES OR REAGENTS IN THE REACTION VESSELS. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00813 2122870-2013-00814.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING DISCREPANT FALSE POSITIVE ACCESS ACCUTNI+3 (TROPONIN I) RESULTS, FOR TWO (2) PATIENTS, OVER TWO SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013; PLEASE REFER TO MEDWATCH REPORT #2122870-2013-00814 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE CUSTOMER REPORTED OBTAINING AN INITIAL NEGATIVE RESULT OF <0.02 NG/ML FOR ONE PATIENT ON (B)(6) 2013. THE CUSTOMER REDREW A SECOND SAMPLE FROM THE PATIENT AND OBTAINED AN ACCUTNI+3 RESULT OF 0.66 NG/ML. A THIRD DRAW WAS OBTAINED FROM THE PATIENT FOUR HOURS LATER AND PRODUCED AN ACCUTNI+3 RESULT OF <0.02 NG/ML. THE CUSTOMER REPORTED THE RESULTS OUT OF THE LABORATORY BUT THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE PHYSICIAN QUESTIONED THE POSITIVE RESULT FROM THE SECOND DRAW AND THE CUSTOMER REPEATED THE SAMPLE AND OBTAINED A RESULT OF 0.01 NG/ML. THE CUSTOMER THEN REPEATED THE SAMPLE ON AN ALTERNATE NON-BECKMAN COULTER ANALYZER AND OBTAINED A NEGATIVE RESULT. THE SAMPLES WERE COLLECTED IN GREEN TOP PLASMA TUBES AND CENTRIFUGED AT 3000 RPM FOR 10 MINUTES. ALL THREE LEVELS OF QUALITY CONTROL (QC) RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. SYSTEM CHECK WHICH WAS RUN ON (B)(6) 2013 PASSED WITHIN SPECIFICATIONS. ACCESS ACCUTNI+3 REAGENT LOT NUMBER 230695 AND CALIBRATOR LOT NUMBER 228308 WERE USED IN CONJUNCTION WITH THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504970 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1