BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4182530 · Received October 17, 2014

    Report

    Report Number
    1061932-2014-02600
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 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 ANALYZER AND OBSERVED ERRATIC SCATTER READINGS WHILE TROUBLESHOOTING AND FOUND THE SCATTER SENSOR MALFUNCTIONED. THE FSE INSTALLED A 3 ELEMENT SCATTER SENSOR ((B)(4)), RAN LATRON IN SERVICE MODE AND MADE ADJUSTMENTS WITH NO FURTHER PROBLEMS. THE FSE RAN 15 SAMPLES WITH NO PROBLEMS, AND RAN CONTROLS WITH NO PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCREASED NUMBER OF FALSE BASOPHILIA MESSAGES ASSOCIATED WITH THE DIFFERENTIAL RESULTS AND AN ERROR CONDITION OF VOTE OUTS (NON-NUMERIC RESULTS) FOR THE RETICULOCYTE PARAMETER 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
    661073 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1