BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3864544 · Received June 10, 2014

    Report

    Report Number
    1061932-2014-01301
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    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

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND THE QUALITY CONTROL (5C CELL CONTROL) WAS RUNNING HIGH AND ERRATIC RESULTS ON THE ABNORMAL 1 CONTROL LEVEL. THE FSE CHECKED THE MIXING BUBBLES DURING THE CYCLE AND FOUND NO PROBLEMS. THE FSE ALSO FOUND THE RBC (RED BLOOD CELL) DISPENSER WAS RUBBING ON THE INSIDE OF THE DISPENSER AND DELAYING THE STROKE OF THE SYRINGE FROM REACHING THE TOP OF THE DISPENSER PROPERLY. THE FSE REPLACED THE RBC DILUENT DISPENSER AND RESOLVED THE ISSUE REPORTED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE RED BLOOD CELL (RBC) PARAMETER WAS RECOVERING HIGH RESULTS ON THE QUALITY CONTROL SAMPLE (5C ABNORMAL I CONTROL) 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 ANALYZER. 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
    341430 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1