BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2678503 · Received August 1, 2012

    Report

    Report Number
    1061932-2012-02242
    Event Type
    Injury
    Date Received
    August 1, 2012
    Date of Event
    June 6, 2012
    Report Date
    July 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE COULTER LH 750 HEMATOLOGY ANALYZER DID NOT MALFUNCTION. THE EVENT WAS CAUSED BY USE ERROR. A CORRECT RESULT FROM THE INSTRUMENT WAS TAKEN BY A LABORATORY TECHNICIAN. THE CORRECT RESULT FROM INSTRUMENT WAS MANUALLY MULTIPLIED INCORRECTLY BY THE LABORATORY TECHNICIAN AND THE ERRONEOUS CALCULATED RESULT WAS REPORTED OUTSIDE THE LABORATORY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ERRONEOUS BODY FLUID (SYNOVIAL FLUID) WHITE BLOOD CELL RESULT HAD BEEN REPORTED FROM THE LABORATORY AND HAD RESULTED IN THE PATIENT RECEIVING AN UNNECESSARY ARTHROSCOPIC KNEE SURGICAL PROCEDURE. THE COULTER LH 750 HEMATOLOGY ANALYZER HAD CORRECTLY CALCULATED THE PATIENT WHITE BLOOD CELL RESULT, HOWEVER, THE LABORATORY TECHNICIAN HAS SUBSEQUENTLY MANUALLY MULTIPLIED THE RESULT INCORRECTLY AND REPORTED THE ERRONEOUSLY CALCULATED RESULT FROM THE LABORATORY. THE ERRONEOUSLY CALCULATED RESULT WAS THE IMPETUS FOR THE UNNECESSARY SURGERY. THE PATIENT OUTCOME WAS FINE WITH NO HARM TO THE PATIENT. CONTROLS WERE EXECUTED BEFORE THE INCIDENT AND WERE WITHIN THE EXPECTED RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. NO SPECIFIC PATIENT INFORMATION OR ADDITIONAL INSTRUMENT/PARAMETER PERFORMANCE INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other