BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2900652 · Received January 7, 2013

    Report

    Report Number
    2122870-2013-00009
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 9, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, WHICH FAILED TO PASS WITHIN INSTRUMENT SPECIFICATIONS. THE FSE DISCOVERED A SMALL FLUID SPILL IN THE INCUBATOR TRACK OF THE INSTRUMENT. AS A PRECAUTION, THE FSE REPLACED THE INCUBATOR BELT CLIPS. HIGH SENSITIVITY SYSTEM CHECK WAS PERFORMED AND PASSED WITHIN INSTRUMENT SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. THE FSE INDICATED DISCUSSION WITH CUSTOMER REVEALED THE SPECIMEN IN QUESTION LIKELY HAD FIBRIN ISSUES DUE TO ANTICOAGULANT THERAPY. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR SEVERAL PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. SUBSEQUENT ANALYSES OF THE PATIENT SAMPLES, ON THE SAME ANALYZER, RECOVERED LOWER RESULTS WITHIN THE RISK STRATIFICATION AND WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY AS THE CUSTOMER QUESTIONED THE VALUES. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7581 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1