BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 844597 · Received February 13, 2007

    Report

    Report Number
    2122870-2007-00036
    Event Type
    Other
    Date Received
    February 13, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 13, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS IN RANGE IN 01/2007. QC WAS PERFORMED THE FOLLOWING DAY, IN THE MORNING AND AGAIN IN THE EVENING. LEVEL 2 QC FAILED IN THE EVENING. SYSTEM CHECK PERFORMED THE NEXT DAY PASSED. THE SPECIMENS WERE SERUM TYPE SAMPLES. THE INITIAL RESULT OF SAMPLE A (1.6NG/ML) WAS NOT FOUND IN ARCHIVE DATA SUPPLIED BY THE CUSTOMER. SAMPLE A WAS ALSO RUN VIA A DIFFERENT METHOD AND WAS FLAGGED AS HAVING A FIBRIN CLOT OBSTRUCTION. IN ADDITION, CUSTOMER OBSERVED VISIBLE CLOTS FROM THIS SAMPLE WITH USE OF WOODEN SAMPLE STICK. THIS SAMPLE WAS THEN POURED OFF INTO ANOTHER GLASS TUBE WHERE CUSTOMER ATTRACTED ADDITIONAL FIBRIN CLOTS. PER CUSTOMER, SAMPLE B WAS HEMOLYZED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE EXPERIENCED ISSUES WITH FAILING CARRYOVER. NO ADDITIONAL INFORMATION REGARDING SERVICE IS AVAILABLE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULTS FROM A SINGLE PATIENT SAMPLES THAT WERE GENERATED BY THE UNICEL DXL 800 ACCESS INSTRIUMENT. A PATIENT SAMPLE (A) WAS TESTED FOR ACCU TNI AND A RESULT OF 1.6NG/ML WAS OBTAINED. THE CUSTOMER RE-TESTED SAMPLE A AND THE REPEATED ACCU TNI RESULT WAS 0.01NG/ML. THE CUSTOMER COLLECTED A FRESH SAMPLE (B) FROM THE PATIENT AND TESTED FOR ACCU TNI AND OBTAINED RESULT OF 0.98NG/ML. THE CUSTOMER VERBALLY COMMUNICATED THAT SAMPLE B WAS RE-TESTED AND THE REPEATED ACCU TNI RESULT WAS 0.01NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA