BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3833925 · Received May 27, 2014

    Report

    Report Number
    1061932-2014-01097
    Event Type
    Malfunction
    Date Received
    May 27, 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
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE OBSERVED A PIN HOLE LEAK IN THE TUBING AT PINCH VALVE PV49. THE FSE REPLACED TUBING AT PINCH VALVE PV49 TO RESOLVE THE ISSUE. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NEEDLE CARTRIDGE OF THE COULTER LH 500 HEMATOLOGY ANALYZER LEAKED ABOUT 20 ML OF DILUENT ONTO THE COUNTER WHILE RUNNING 5C CONTROLS. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR WAS WEARING A LAB COAT, GLOVES, AND EYE GLASSES AT THE TIME OF THE INCIDENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED FOR THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310941 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1