BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2252903 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03469
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 17, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SERUM WITH A CLEAR APPEARANCE. SAMPLE WAS ASPIRATED FROM THE PRIMARY TUBE FOR ANALYSIS. RESULT WAS QUESTIONED WHEN MONITORING THE ACCUTNI RESULTS 12 HOURS LATER AND THE RESULT WAS NEGATIVE. ON (B)(4) 2010, THE FIELD SERVICE ENGINEER REPLACED THE WASH PUMP AND MIXER PULLEYS. ALIGNMENTS WERE VERIFIED. HIGH SENSITIVITY SYSTEM CHECK AND QUALITY CONTROL WERE WITHIN SPECIFICATIONS. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THE RELATED MDR IS 2122870-2011-03468.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES TESTED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL TEST RESULT WAS ABOVE THE NORMAL REFERENCE RANGE, AND BELOW THE AMI (ACUTE MYOCARDIAL INFARCTION) CUTOFF OF 0.50 NG/ML. THE TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS WAS PERFORMED ON ANOTHER UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE TEST RESULTS WERE IN NORMAL RANGE. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THIS IS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR ONE OF TWO PATIENTS TESTED ON TWO DIFFERENT WORK SHIFTS ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCU TNI