BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4014238 · Received August 18, 2014

    Report

    Report Number
    1061932-2014-01952
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    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)(6) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND OBSERVED THE RED BLOOD CELL COUNT (RBC) AND HEMOGLOBIN FAILURE REPORTED BY THE CUSTOMER. THE FSE FOUND THE RBC APERTURE WAS LEAKING AIR. HE REPLACED THE O-RINGS ON THE APERTURE BUT THIS DID NOT RESOLVE THE ISSUE. THE FSE REPLACED THE RBC APERTURE AND RESOLVED THE ISSUE REPORTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FAILING THE LINEARITY FOR THE RED BLOOD CELL COUNT (RBC) AND HEMOGLOBIN PARAMETERS ON THE CAP (COLLEGE OF AMERICAN PATHOLOGISTS) SURVEY MATERIAL WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. 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
    492659 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1