BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI® 725 CLINICAL SYSTEM

    MDR report key: 2233724 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03183
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE 1/1 WAS A LINE DRAW BY NURSING STAFF, AND SAMPLE 1/2 WAS A PERIPHERAL DRAW PERFORMED BY LAB STAFF. BOTH SAMPLES WERE FULL DRAWS INTO LITHIUM HEPARIN TUBES WITH GEL. THE SAMPLES WERE CENTRIFUGED AT 8000 RPM FOR 3 MINUTES AT ROOM TEMPERATURE. TWO LEVELS OF QC ARE RUN ONCE DAILY AND HAD BEEN RECOVERING WITHIN +/- 2SD FROM THE ESTABLISHED MEAN PRIOR TO AND AFTER THE EVENT. SYSTEM CHECKS WERE PERFORMED ON (B)(4) 2011. ALL PORTIONS RECOVERED WITHIN THE PUBLISHED SPECIFICATIONS. THE FSE WAS ONSITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) PERFORMED HARDWARE VERIFICATION PER SERVICE MANUAL. BOTH HIGH SENSITIVITY SYSTEM CHECK AND SYSTEM CHECK PASSED WITHIN THE PUBLISHED SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. NO ROOT CAUSE FOR THIS EVENT WAS DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BEC) CONCERNING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUTOFF, GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON THE SAME AND ON A SUBSEQUENT DRAW PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DOES NOT KNOW IF THE PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI® 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR