BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 2930946 · Received January 28, 2013

    Report

    Report Number
    2122870-2013-00059
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) PATIENT RESULTS FOR ONE PATIENT INVOLVING AN ACCESS 2 IMMUNOASSAY ANALYZER PORTION OF THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER NOTED THAT THE PATIENT'S FIRST TWO SAMPLES RECOVERED WITHIN THE NORMAL RANGE OF THE ASSAY. THE THIRD SAMPLE PRODUCED AN ELEVATED RESULT WITHIN THE RISK STRATIFICATION RANGE OF 0.09 NG/ML WITH A REPEAT OF 0.00 NG/ML ON THE SAME INSTRUMENT. A PRECISION STUDY OF 4 NEGATIVE PATIENT SAMPLE PRODUCED ERRATIC RESULTS OF 0.00, 0.00, 0.00 AND 0.10 NG/ML FOR A %CV (COEFFICIENT OF VARIATION) 200%. THE CUSTOMER INDICATED THAT THERE WERE NO CHANGES OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL (QC) AND SYSTEM CHECKS PASSED AT THE TIME OF THE EVENT AND THERE WERE NO SAMPLE INTEGRITY ISSUES OR CONCERNS REPORTED BY THE CUSTOMER FOR THIS EVENT. THE CUSTOMER NOTED THAT THE INSTRUMENT HAD BEEN SERVICED THE PRIOR WEEK TO ADDRESS AN ISSUE WITH A WASH VALVE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED BUT NOTED NO ISSUES WITH THE INSTRUMENT WHICH WOULD HAVE CONTRIBUTED TO THE EVENT. THE FSE PERFORMED A PASSING SYSTEM CHECK AND A PASSING HIGH SENSITIVITY SYSTEM CHECK AND RESULTS MET PUBLISHED SPECIFICATIONS. ACCUTNI REAGENT LOT NUMBER 222575 WAS USED IN CONJUNCTION WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36686 UNICEL® DXC 600I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR