BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 609982 · Received May 31, 2005

    Report

    Report Number
    1061932-2005-00021
    Event Type
    Other
    Date Received
    May 31, 2005
    Date of Event
    April 22, 2005
    Report Date
    May 31, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY LOW PLATELET (PLT) RESULTS FROM TWO (2) DIFFERENT PATIENTS THAT WERE GENERATED BY THE COULTER HMX WITH AUTOLOADER ANALYZER. THE PLT RESULT FROM PATIENT A WAS 49 X 10 TO THE THIRD POWER CELLS/UL. THE PLT RESULT FROM PATIENT B WAS 77 X 10 TO THE THIRD POWER CELLS/UL. THE CUSTOMER INDICATED THAT THE PLT RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT THE COULTER HMX WITH AUTOLOADER INSTRUMENT WAS USED ONLY TO COMPARE THE PLT RESULTS WITH THE RESULTS OBTAINED EARLIER FROM A DIFFERENT INSTRUMENT. THE CUSTOMER INDICATED THAT THE PLT RESULTS FROM COULTER HMX WITH AUTOLOADER CLOSELY MATCHED THE RESULTS OF THE DIFFERENT INTRUMENT (51 X 10 TO THE THIRD POWER CELLS/UL RESPECTIVELY). THE CUSTOMER THEN PERFORMED A MANUAL SLIDE REVIEW FOR PLT. THE PLT RESULT FOR PATIENT A WAS 200-250. THE PLT RESULT FOR PATIENT B WAS APPROXIMATELY 180. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PATIENTS TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HEMETOLOGY ANALYZER GKH BECKMAN COULTER, INC. HMX WITH AUTOLEADER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other