BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2252893 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03422
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A HIGH TROPONIN RESULT WAS RUN IMMEDIATELY PRIOR TO EACH OF THESE SAMPLES. CUSTOMER SUSPECTED CARRYOVER. CUSTOMER PERFORMED CARRYOVER TESTING ON BOTH THE CTA (CLOSED TUBE ALIQUOTTER) AND THE ACCESS 2 INSTRUMENT. DATA PROVIDED BY CUSTOMER SHOWS ALL CARRYOVER TESTING PASSED REQUIREMENTS. SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES WITH GEL SEPARATOR. CENTRIFUGATION FOR 10 MINUTES AT 3300. BOTH SAMPLES WERE RUN ON THE CTA FROM THEIR PRIMARY TUBES. QUALITY CONTROL (QC) IS RUN TWICE DAILY AND IS PROCESSED THROUGH THE CTA. QC HAS BEEN RECOVERING WITHIN RANGE. A SYSTEM CHECK RUN ON (B)(4) 2010 PASSED. CUSTOMER RAN ANOTHER SYSTEM CHECK ON (B)(4) 2010 AFTER THE EVENT, PASSED ALL PARAMETERS. THERE WERE NO EVENT LOG MESSAGES GENERATED WITH THIS EVENT. SERVICE WAS NOT DISPATCHED. ANALYZER PASSED ALL QUALITY CONTROL AND SYSTEM CHECKS EXECUTED BY THE CUSTOMER. 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.

    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 NOT REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS WAS PERFORMED. THE REPEAT TEST RESULTS WERE WITHIN NORMAL RANGE AND WERE REPORTED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    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