BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4243651 · Received November 11, 2014

    Report

    Report Number
    1061932-2014-02810
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 REPLACED THE HEMOGLOBIN CUVETTE RESOLVING THE ERRATIC HEMOGLOBIN RESULTS. THE FSE ALSO IDENTIFIED A WHITE BUILDUP IN THE WHITE BLOOD CELL (WBC) BATH AND REPLACED THE WBC BATH. THE FAILURE MODE IS RELATED TO A WHITE COATING IN BOTH THE WBC BATH AND HEMOGLOBIN CUVETTE. RAW DATA WAS RECEIVED FROM THE CUSTOMER AND ANALYZED. THE ANALYSIS SUPPORTED THE CONCLUSION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC HEMOGLOBIN TEST RESULTS WERE OBTAINED ON AN INTERMITTENT BASIS WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER IN THEIR LABORATORY. A PATIENT CONTROL SAMPLE WAS TESTED ON (B)(6) 2014, AND INCONSISTENT HEMOGLOBIN TEST RESULTS WERE OBTAINED. THE QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS PRIOR TO THE EVENT. HEMOGLOBIN TEST RESULTS FOR THE ABNORMAL II LEVEL OF THE QUALITY CONTROL WERE INTERMITTENTLY HIGH, AND WITHIN ACCEPTABLE LIMITS UPON RETEST. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WERE NO ERRONEOUS TEST RESULTS REPORTED OUT OF THE LABORATORY 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
    727162 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1