BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3892549 · Received June 24, 2014

    Report

    Report Number
    1061932-2014-01419
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND THE CV (COEFFICIENT OF VARIATION) AND GAIN FOR THE LATRON CONTROL WERE HIGH. THE FSE REPLACED AND REALIGNED THE FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LATRON CONTROL WAS OUT OF RANGE WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE ISSUE COULD NOT BE RESOLVED BY THE CUSTOMER PERFORMING THE FLOW CELL FLUSH PROCEDURE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THERE WERE NO 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
    368374 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1