BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3240791 · Received July 22, 2013

    Report

    Report Number
    2122870-2013-00627
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VERIFIED AND NOTED ULTRASONIC VOLTAGES WERE OUT OF SPECIFICATIONS AND REPLACED THE ULTRASONIC PROBE. THE FSE READJUSTED THE TEMPERATURE AND VOLTAGES PER SPECIFICATIONS AND PERFORMED ALIGNMENT. THE FSE DISCOVERED THE VACUUM LIMIT WAS OUT OF SPECIFICATIONS DUE TO CRACKED TUBING IN THE PIPETTOR WASH TOWER ASSEMBLY AND REPLACED THE TUBING. THE FSE CLEANED THE WASH CAROUSEL AND REPLACED THE PERISTALTIC PUMP TUBING AND ASPIRATE PROBE AS THEY WERE DIRTY. THE FSE PRIMED THE INSTRUMENT AND PERFORMED PRECISION TEST FOR TROPONIN FOR THE LOWER LEVEL CARDIAC QUALITY CONTROL (QC). ALL RESULTS PASSED WITHIN SPECIFICATIONS. SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK WERE ALSO WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, FOR SIXTEEN PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. SUBSEQUENT TESTING OF THE PATIENTS¿ SAMPLES, ON AN ALTERNATE ACCESS 2 ANALYZER, WITHOUT ANY ADDITIONAL PROCESSING, PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR ALL OF THE PATIENTS. THE CUSTOMER THEN RE-CENTRIFUGED ALL OF THE QUESTIONED SAMPLES AND REANALYZED THEM AGAIN ON THE ALTERNATE ANALYZER; SIMILAR RESULTS AS THE FIRST REANALYSIS WERE OBTAINED. THE CUSTOMER CEASED ALL PATIENT SAMPLE TESTING. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS ANY IMPACT TO PATIENT CARE. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF PATIENT CONSEQUENCE OR CHANGE TO PATIENT TREATMENT. QUALITY CONTROL (QC) WAS OUT OF SPECIFICATIONS AT THE TIME OF THE EVENT. THE PATIENTS¿ SAMPLES WERE COLLECTED IN SERUM TUBES WITH GEL AND CENTRIFUGED AT 3,000G (RELATIVE CENTRIFUGAL FORCE) FOR 10 MINUTES AT 20ºC. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340055 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1