BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3790413 · Received May 5, 2014

    Report

    Report Number
    1061932-2014-00998
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED VALVE VL48B WAS BROKEN AND WASTE WAS BACKING UP THROUGH THE SYSTEM. THE FSE REPLACED THE BROKEN PINCH VALVE AND BLEW THE FLUID OUT OF THE PRESSURE LINES AND SET THE DIFF PRESSURE. THESE ACTIONS RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ERROR CONDITION OF "DIFF SAMPLE PRESSURE ABOVE LIMIT" WAS GENERATED WHEN USING THE COULTER® LH 750 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. 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
    268187 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1