BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2471088 · Received February 28, 2012

    Report

    Report Number
    1061932-2012-00703
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 8, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER. REVIEWED QUALITY CONTROL AND STARTUP DATA. VERIFIED APERTURE VOLTAGE, FLOW RATE SETTINGS, FLOW CELL ALIGNMENTS, VOLTAGES AND PRESSURES. ALL MET SPECIFICATIONS. CAUSE COULD NOT BE DETERMINED, ALLEGED FAILURE WAS NOT REPRODUCED. PRODUCT LABELING WAS EVALUATED. COULTER LH 750 HEMATOLOGY ANALYZER OPERATOR'S GUIDE, PN4277249, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON YOUR PATIENT POPULATION. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), ACTION AND CRITICAL LIMITS, DEFINITIVE FLAGS, SUSPECT FLAGS, PARAMETER CODES, DELTA CHECKS, DECISION RULES AND SYSTEM ALARMS. BECKMAN COULTER INC. RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. THERE MAY BE SITUATIONS WHERE THE PRESENCE OF A RARE EVENT MAY FAIL TO TRIGGER A SUSPECT MESSAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS NUCLEATED RED BLOOD CELL (NRBC) TEST RESULTS WERE OBTAINED FOR ONE PATIENT SAMPLE WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL BLOOD SMEAR REVIEW. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. QUALITY CONTROL, BEFORE AND AFTER THE EVENT, WAS WITHIN ACCEPTABLE RANGES. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR