BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCCULT ICT

    MDR report key: 2001634 · Received February 25, 2011

    Report

    Report Number
    2518658-2011-00004
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    KHE
    PMA / PMN Number
    K080812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEST WAS ON FECAL SAMPLE. INVESTIGATION BY RAPIDS QC DID NOT CONFIRM THE CUSTOMER COMPLAINT. SERVICE EXPLAINED THE IMPORTANCE OF PROPER BUFFER ADDITION TECHNIQUE TO THE CUSTOMER. THE CUSTOMER NOTED THAT THEY MAY NOT HAVE PERFORMED THE TEST AS PER THE PRODUCT INSTRUCTIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BCI) TO REPORT RECEIVING NEGATIVE TEST RESULTS WITH COLON CANCER PATIENTS THAT WERE TESTED WITH HEMOCCULT ICT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY; HENCE, NO INJURY OR DEATH HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCCULT ICT HEMOCCULT ICT TEST DEVICE KHE BECKMAN COULTER INC HEMOCCULT ICT TEST DEVICE M002693

    Patients

    Seq Age Sex Outcome Treatment
    1