BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 2905619 · Received January 9, 2013

    Report

    Report Number
    2122870-2013-00010
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: WASH WHEEL BEARINGS. A HARDWARE MALFUNCTION IS THE LIKELY CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED ERRONEOUSLY ELEVATED TROPONIN, CK-MB, AND MYOGLOBIN RESULTS FOR FOUR (4) PATIENTS AND AN ERRONEOUSLY ELEVATED BNP (B-TYPE NATRIURETIC PEPTIDE) RESULT FOR ONE PATIENT. THE CUSTOMER PERFORMED REPEAT ASSAYS ON THE LABORATORY'S ALTERNATE INSTRUMENT AND OBTAINED EXPECTED LOWER RESULTS. THE CUSTOMER STATED THAT THE ERRONEOUS RESULTS FOR TWO OF THE PATIENTS WERE RELEASED OUT OF THE LABORATORY, BUT CONFIRMED THAT THERE WAS NO CHANGE TO PATIENT TREATMENT. THERE WAS NO REPORT OF DEATH OR INJURY ASSOCIATED WITH THIS EVENT. QC AND CALIBRATIONS WERE PERFORMING WITHIN THE SPECIFICATIONS PRIOR TO THE EVENT. A ROUTINE SYSTEM CHECK PERFORMED ON (B)(4) 2012 PASSED WITHIN THE SPECIFICATIONS. HOWEVER, A SYSTEM CHECK PERFORMED AS A TROUBLESHOOTING MEASURE ON THE DAY OF THE EVENT FAILED THE WASHED PORTION. THE CUSTOMER REPORTED SEVERAL ERRORS POSTED IN THE ANALYZER'S EVENT LOG AT THE TIME OF TESTING: LUMINOMETER READ FAILURE, SAMPLE COUNTS OUTSIDE LIMITS, AND STATUS CONTROLLER INITIALIZATION ERROR. BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE FOUND A HIGH SENSITIVITY SYSTEM CHECK WAS FAILING AND NOTED THE WASH WHEEL BEARINGS WERE ROUGH AND HAD DRIED REAGENT ON THE WASH WHEEL. THE FSE CLEANED THE WASH WHEEL AND BEARINGS AND THE INSTRUMENT PASSED THE HIGH SENSITIVITY SYSTEM CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12509 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR