BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2589552 · Received May 27, 2012

    Report

    Report Number
    2122870-2012-01396
    Event Type
    Malfunction
    Date Received
    May 27, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (DXI 600) GENERATED AN ERRONEOUS CREATINE KINASE-MB (CK-MB) RESULT. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THERE WAS NO INJURY OR CHANGE IN PATIENT TREATMENT. CUSTOMER REPORTED THAT ACCESS CK-MB REAGENT KIT (2 X 50 TESTS), LOT 123055, AND ACCESS CK-MB CALIBRATORS (S0-S5), LOT 115362, WERE USED IN CONJUNCTION WITH THE DXI 600 ANALYZER. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE AND VERIFIED INSTRUMENT HARDWARE. THE FSE DID NOT FIND ANY MALFUNCTION IN INSTRUMENT HARDWARE HAD OCCURRED. THE FSE NOTED THAT THE PATIENT SAMPLE HAD RED STREAKS IN THE GEL, A RED MASS ON TOP OF THE GEL AND A THICKENED SERUM COLORED SUBSTANCE FLOATING AT THE TOP. THE FSE INQUIRED ABOUT THE CONDITION OF THE SAMPLE. CUSTOMER REPORTED THAT THEY BELIEVED THE SUBSTANCE WAS FIBRIN AND WAS TO BE EXPECTED BECAUSE THE PATIENT SAMPLE HAD BEEN RUN 14 HOURS EARLIER. THE CONDITIONS THE SAMPLE WAS STORED IN DURING THE 14 HOUR TIME PERIOD IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability