BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2821568 · Received November 6, 2012

    Report

    Report Number
    2122870-2012-01859
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS A FULL SAMPLE COLLECTED BY EMERGENCY DEPARTMENT PERSONNEL INTO A BECTON DICKINSON GOLD TOP SERUM SEPARATOR TUBE WITH A GEL BARRIER AND CENTRIFUGED AT 3000 RPM FOR 10 MINUTES AT ROOM TEMPERATURE. NO SAMPLE INTEGRITY ISSUES WERE NOTED WITH THE SAMPLE. ALL SYSTEM PARAMETERS (INCLUDING QC, CALIBRATION, AND SYSTEM CHECKS) WERE PERFORMING WITHIN SPECIFICATIONS. A SYSTEM CHECK RUN ON THE MORNING OF THE EVENT AS A PART OF WEEKLY MAINTENANCE HAD ALL VALUES WITHIN PASSING SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS EVENT. A SYSTEM CHECK WAS PERFORMED AND WAS FOUND TO BE PASSING. ALTHOUGH THIS SYSTEM CHECK WAS PASSING, THE WASHED PORTION WAS FOUND TO HAVE AN ELEVATED %CV (COEFFICIENT OF VARIATION). FSE FOUND THAT THE ASPIRATE PROBE TUBING FOR ASPIRATE PROBE #1 WAS LOOPED OVER THE FEED LINE FOR THE SAMPLE PROBE. FSE INSTRUCTED THE CUSTOMER IN PROPERLY ADDRESSING THE ASPIRATE PROBES AND ASSOCIATED TUBING. ALL ASPIRATE PROBES WERE PROACTIVELY REPLACED AND INSTRUMENT PERFORMANCE WAS VERIFIED WITH A PASSING SYSTEM CHECK, A PASSING HIGH SENSITIVITY SYSTEM CHECK AND PERFORMANCE OF ALL LEVELS OF QC. USE ERROR IS THE CAUSE OF THIS EVENT AS THE CUSTOMER HAD ROUTED THE ASPIRATE PROBE TUBING OF ASPIRATE PROBE #1 INCORRECTLY (LOOPED THE ASPIRATE PROBE TUBING OVER THE FEED LINE FOR THE SAMPLE PROBE).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ON ONE PATIENT FROM THE HOSPITAL'S EMERGENCY DEPARTMENT. THE PATIENT SAMPLE GAVE AN INITIAL ACCUTNI RESULT OF 11.17 NG/ML WHICH WAS RELEASED FROM THE LABORATORY AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATMENT FOR A MYOCARDIAL INFARCTION WAS STARTED; HOWEVER, THE EXACT TREATMENT ADMINISTERED TO THE PATIENT IS UNKNOWN BY THE CUSTOMER. THE PATIENT WAS REDRAWN THE FOLLOWING MORNING, AND AN ACCUTNI RESULT OF 0.01 NG/ML (WITHIN THE NORMAL REFERENCE RANGE) WAS OBTAINED. THIS RESULT PROMPTED THE TESTING TECHNICIAN TO REPEAT THE INITIAL SAMPLE ON THE ORIGINAL INSTRUMENT WHICH GAVE A RESULT OF 0.02NG/ML AND ON A DIFFERENT INSTRUMENT IN THEIR LABORATORY WHICH GAVE RESULTS OF 0.03NG/ML AND 0.02NG/ML (RUN IN DUPLICATE). THE INITIAL RESULT WAS CORRECTED AND THE PATIENT'S PHYSICIAN WAS INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization