BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2464203 · Received February 22, 2012

    Report

    Report Number
    1061932-2012-00487
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 25, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. THE APPLICATION SPECIALIST RAN S-CAL TO CHECK INSTRUMENT CALIBRATION. THE REFERENCE VALUE S-CAL WAS 12.6 AND S-CAL CHECK RESULT WAS 12.7. THE CUSTOMER AT PRESENT DOES NOT SEND R FLAGS OR H&H MESSAGES FROM REMISOL TO THEIR LIS, AND THEREFORE MISSED THE H&H FAILURE. THE CUSTOMER IS LOOKING AT HOW THIS MESSAGE CAN BE RECEIVED BY THERE LIS TO PREVENT PROBLEMS IN THE FUTURE. THE ROOT CAUSE IS UNKNOWN, BUT MAY BE SAMPLE RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULTS OF 11.9 AND 11.8 G/DL WERE GENERATED BY UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM FOR TWO SPECIMENS FROM A KNOWN POLYCYTHAEMIC PATIENT. AN OPERATOR DEFINED H&H CHECK FAILED ERROR MESSAGE WAS OBSERVED BUT THERE WAS NO INSTRUMENT GENERATED MESSAGES FOR HGB PARAMETER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. TESTING ON AN ALTERNATE INSTRUMENT (COULTER LH500 HEMATOLOGY ANALYZER) PRODUCED HIGHER HGB RESULTS OF 12.5 AND 12.4 G/DL, WHICH WERE CONFIRMED BY A REFERENCE METHOD (HEMOCUE). HGB RESULT OF 12.5 G/DL WAS REPORTED OUT OF THE LABORATORY. ADDITIONALLY, A DISCREPANCY IN PLATELET COUNTS WAS NOTED BETWEEN THE DXH800 AND LH500 INSTRUMENTS, BUT THE DXH800 RESULTS OF 717 AND 689 (X 10^3 CELLS/UL) WERE CONFIRMED BY THE REFERENCE FLOW CYTOMETRY RESULTS OF 672 AND 721(X 10^3 CELLS/UL) AND WERE CONSIDERED CORRECT. LH500 FLAGGED THE PLATELET RESULTS AND THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR