BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2845550 · Received November 26, 2012

    Report

    Report Number
    2122870-2012-01915
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATING ERRONEOUSLY ELEVATED TROPONIN I (ACCUTNI) RESULTS FOR 3 PATIENTS FROM AN ACCESS 2 IMMUNOASSAY ANALYZER PART OF A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT ONE OF THE PATIENTS WAS AN EMERGENCY ROOM (ER) PATIENT WHO RECOVERED AN ERRONEOUS ACCUTNI RESULT OF 0.12 NG/ML. THE RESULT IS CONSIDERED POSITIVE AS THE CUSTOMER CUTOFF IS SET AT 0.06 NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC CATHETERIZATION LABORATORY. A CATHETERIZATION WAS THEN PERFORMED AS A RESULT OF THE INITIAL ERRONEOUSLY ELEVATED RESULT. THE DOCTOR HAD ASKED FOR THE SAMPLE TO BE RERUN APPROXIMATELY 2 HOURS AFTER THE ORIGINAL RUN AND A RESULT OF 0.00 NG/ML WAS OBTAINED FROM THE ORIGINAL INSTRUMENT. THE CUSTOMER ALSO NOTED THAT THE PATIENT'S SAMPLE WAS SLIGHTLY HEMOLYZED. THE CUSTOMER IS CURRENTLY UNAWARE OF THE THE PATIENT'S CURRENT STATUS AND DID NOT WANT TO INVESTIGATE FURTHER. PLEASE SEE MEDWATCH #2122870-2012-01926 FOR THE REPORT ON THE OTHER 2 PATIENTS. THE CUSTOMER HAD INDICATED THAT ALL TROPONIN SAMPLES ARE COLLECTED IN LITHIUM HEPARIN PLASMA GEL SEPARATOR TUBES. THE SAMPLES ARE THEN SPUN FOR 10 MINUTES AT 3000 RPMS AND PLACED ONTO THE CLOSED-TUBE ALIQUOTER (CTA) FOR PROCESSING. THREE LEVELS OF QC ARE RUN ONCE PER DAY AND WERE WITHIN RANGE. THE CUSTOMER HAD REPEATED QC AFTER THE THIRD QUESTIONED RESULT AND QC WAS WITHIN RANGE. THE CUSTOMER CURRENTLY DOES NOT HAVE A STANDARD REPEAT PROTOCOL FOR POSITIVE TROPONIN RESULTS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED BUT DID NOT DISCOVER ANY SIGNIFICANT FINDINGS WHILE ONSITE. THE FSE PERFORMED A SYSTEM CHECK, VERIFIED ALIGNMENTS, RECALIBRATED TROPONIN AND COMPLETED A SUCCESSFUL PRECISION RUN. THE CAUSE OF THIS EVENT IS UNKNOWN. ACCUTNI REAGENT PART NUMBER A78803 AND LOT NUMBER 224072 AND ACCUTNI CALIBRATORS PART NUMBER 33345 AND LOT NUMBER 222575 WERE USED IN CONJUNCTION WITH THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other