BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2261733 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03286
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    January 10, 2010
    Report Date
    January 11, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010, THE FIELD SERVICE ENGINEER (FSE) PERFORMED THE HIGH SENSITIVITY SYSTEM CHECK, WHICH FAILED THE FOAM PORTION. FSE DETERMINED THE THREE ASPIRATE PROBES WERE NOT ASPIRATING AT THE SAME RATE AND REPLACED THE PERI PUMP TUBING AND THE ASPIRATE PROBES. HIGH SENSITIVITY SYSTEM CHECK AND A 40 POINT PRECISION RUN MET PUBLISHED SPECIFICATIONS. NO OTHER HARDWARE ISSUES WERE NOTED. ROOT CAUSE WAS NOT DETERMINED, BUT MAY BE RELATED TO THE PARTS REPLACED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS IS EVENT 5 OF 13 REPORTED BY THIS CUSTOMER. THE 13 MDRS ARE: 212870-2011-03282, 03283, 03284, 03285, 03287, 03288, 03289, 03290, 03291, 03292, 03293 AND 03294.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULTS WERE OBTAINED FOR 13 PT SAMPLES WHEN USING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE INITIAL TEST RESULTS WERE 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 LAB. REPEAT ANALYSIS WAS PERFORMED ON ANOTHER UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE TEST RESULTS WERE WITHIN THE NORMAL RANGE. IMPACT TO PT TREATMENT IS UNK. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS IS EVENT 5 OF 13 REPORTED BY THIS CUSTOMER FOR 13 PT SAMPLES TESTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCU TNI