BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 2872085 · Received December 13, 2012

    Report

    Report Number
    2122870-2012-01969
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 17, 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
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 (ACCUTNI) RESULTS FOR TWENTY TWO (22) PATIENTS OVER THE COURSE OF THREE DAYS: (B)(6) 2012. THE CUSTOMER REPEATED SOME OF THE SAMPLES ON THE ORIGINAL INSTRUMENT, AND OBTAINED RESULTS OUTSIDE THE PRECISION CLAIMS. THE CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT THERE WAS NO REPORT OF DEATH, INJURY, OR IMPACT TO PATIENT TREATMENT. REPEAT TESTS PERFORMED ON AN ALTERNATE ACCESS ANALYZER PRODUCED ACCUTNI RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR ALL TWENTY TWO (22) SAMPLES. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLES WERE COLLECTED INTO GREEN TOP LITHIUM HEPARIN PLASMA TUBES WITHOUT GEL SEPARATORS, AND CENTRIFUGED FOR 10 MINUTES. THE CENTRIFUGATION SPEED WAS NOT PROVIDED. THE SAMPLES WERE ANALYZED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). THE CUSTOMER DID NOT PROVIDE QC OR SYSTEM CHECK DATA. THE CUSTOMER REPORTED THAT THE ANALYZER HAD BEEN RECEIVING "WASH VALVE/PUMP MOTION" ERRORS, AND CALIBRATION FAILURE AFTER THE EVENT. BEC FIELD SERVICE ENGINEER (FSE) NOTED MICRO BUBBLES IN THE WASH PUMP, AND REPLACED THE WASH PUMP AND TUBING. THE FSE CHECKED ALL ALIGNMENTS AND VOLTAGES, AND PERFORMED SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, CALIBRATION, QC, AND PRECISION TESTS. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. THE CUSTOMER THEN RAN PATIENT SAMPLE CORRELATION STUDIES ON THE TWO ACCESS ANALYZERS AND ALL RESULTS CORRELATED BETWEEN THE TWO ANALYZERS. THIS REPORT DOCUMENTS ERRONEOUS ACCUTNI RESULTS GENERATED FOR TWENTY (20) PATIENTS ON (B)(6) 2012. THE RELATED EVENTS ON (B)(6) 2012 ARE DOCUMENTED IN MDR #2122870-2012-01967 AND #2122870-2012-01968, RESPECTIVELY.

    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. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1