BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 5040917 · Received August 29, 2015

    Report

    Report Number
    1061932-2015-01379
    Event Type
    Malfunction
    Date Received
    August 29, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(4) 2015. THE FSE FOUND A BROKEN PINCH VALVE VL88 TUBING FOR THE RETIC LATRON CONTROL AND THE TUBING WAS REPLACED. THE FSE FOUND THE LASER DISPLAYING A SLIGHT PULSE WHEN VIEWING THE SCATTER SENSOR; THE RETIC LIGHT SCATTER (LS) OFFSET WAS CONFIRMED AS UNSTABLE. THE SCATTER SENSOR AND THE LASER ASSEMBLY WERE BOTH REPLACED, RESOLVING THE REPORTED PROBLEM. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ALL THREE LEVELS OF RETICULOCYTE (RETIC) CONTROLS WERE HIGH ON A COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER CLEANED THE SHEAR VALVES WITH NO RESOLUTION AND ALSO PERFORMED A RETIC REPRODUCIBILITY USING A PATIENT SAMPLE, WHICH WAS POOR. A SERVICE VISIT WAS REQUESTED. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573668 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1