BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2870594 · Received December 12, 2012

    Report

    Report Number
    1061932-2012-02800
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RUN BEFORE INCIDENT WAS WITHIN RANGE AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. SAMPLE COLLECTION DETAILS WERE NOT PROVIDED; HOWEVER THE SAMPLE HAD A PLASMA REPLACEMENT PROCEDURE PERFORMED ON IT PRIOR TO ANALYSIS ON THE LH780 INSTRUMENT. BEC CUSTOMER TECHNICAL SPECIALIST (CTS) REVIEWED A PLASMA REPLACEMENT PROCEDURE WITH THE CUSTOMER. PER BECKMAN COULTER LABELING, VERY HIGH WBC COUNTS ARE LISTED AS ONE OF THE INTERFERING CONDITIONS FOR HGB / RBC COUNTS: "PER LH500 IFU, PN: (B)(4), KNOWN INTERFERING SUBSTANCES AND CONDITIONS: RBC - VERY HIGH WBC COUNT, HIGH CONCENTRATION OF VERY LARGE PLATELETS, AGGLUTINATED RBCS, RBCS SMALLER THAN 36 FL, SPECIMENS CONTAINING FIBRIN, CELL FRAGMENTS, OR OTHER DEBRIS SUCH AS PEDIATRIC AND ONCOLOGY SPECIMENS. HGB - VERY HIGH WBC COUNT, SEVERE LIPEMIA, HEPARIN, CERTAIN UNUSUAL RBC ABNORMALITIES THAT RESIST LYSING, OR ANYTHING THAT INCREASES THE TURBIDITY OF THE SAMPLE SUCH AS ELEVATED LEVELS OF TRIGLYCERIDES."

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT ERRONEOUS HIGH HGB AND HCT RESULTS WERE REPORTED OUT FROM THEIR COULTER LH 500 HEMATOLOGY ANALYZER DUE TO A PATIENT'S HIGH WBC COUNT (LEUKOCYTOSIS) AS COMPARED TO THE SAME PATIENT'S SAMPLE SENT TO A SISTER HOSPITAL WHERE A PLASMA REPLACEMENT PROCEDURE WAS PERFORMED ON THE SAMPLE AND THEN IT WAS RUN ON THEIR LH780 INSTRUMENT. ONLY LIS PRINTOUTS WERE PROVIDED FOR THIS EVENT, THEREFORE INSTRUMENT FLAGGING COULD NOT BE ASSESSED. LH780 RESULTS WERE CONSIDERED CORRECT. BEC REVIEW OF THE DATA SHOWED THE LH500 ALSO GAVE HIGH RBC, MCH AND MCHC RESULTS COMPARED TO THE CORRECT LH780 RESULTS. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR