BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4112397 · Received September 24, 2014

    Report

    Report Number
    1061932-2014-02428
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPLACED THE RBC (RED BLOOD CELL) DISPENSER DUE TO BUBBLES ENTERING THE RBC DILUENT DISPENSER (PUMP). THE FSE ALSO REPLACED THE HEMOGLOBIN CUVETTE TO RESOLVE FREQUENT HEMOGLOBIN INCOMPLETE TEST RESULTS (NON-NUMERIC RESULTS) AND ELEVATED HEMOGLOBIN BACKGROUND COUNTS ON STARTUP, AND UPON RERUN WOULD PASS. FREQUENT 60 PSI LOW ERROR MESSAGES WERE OBSERVED ON THE ERROR LOG; THE FSE FOUND PRESSURE TUBING CRACKED AT THE PNEUMATIC SUPPLY (PUMP) CAUSING THE ERRORS. THE PRESSURE TUBING WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER REPORTED HEMOGLOBIN INCOMPLETE TEST RESULTS WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. WHILE SERVICING THE ANALYZER, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) IDENTIFIED COMPONENTS THAT REQUIRED REPLACEMENT. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593207 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1