BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER AC.T 5DIFF AUTOLOADER HEMATOLOGY ANALYZER

    MDR report key: 709404 · Received May 3, 2006

    Report

    Report Number
    1061932-2006-00013
    Event Type
    Other
    Date Received
    May 3, 2006
    Date of Event
    April 3, 2006
    Report Date
    May 3, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUS HEMOGLOBIN (HBG) AND HEMATOCRIT (HCT) RESULTS FROM A SINGLE PT SAMPLE GENERATED BY COULTER ACT 5DIFF AUTOLOADER HEMATOLOY ANALYZER. AN INITAL HGB RESULT WAS 8.4G/DL. AN INITIAL HCT WAS 24.0%. BOTH RESULTS WERE PRINTED WITH "L" FLAG. THE HGB AND HCT RESULTS WERE REPORTED OUT OF THE LAB. ON THE NEXT DAY, A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR HGB AND HCT. THE HBG RESULTS WAS 12.1G/DL. THE HCT RESULT WAS 35.3%. THE REDRAWN SAMPLE WAS RE-TESTED AND SIMILAR RESULTS FOR HBG AND HCT WERE OBTAINED. (SEE B6) THE CUTOMER THEN RE-TESTED THE PT ORIGINAL SAMPLE FOR HBG AND HCT. THE REPEATED HGB WAS 11.6G/DL. THE REPEATED HCT WAS 33.9%. AGAIN, BOTH RESULTS WERE PRINTED WITH "L" FLAG. BASED ON AVAILABLE INFO, THERE WAS NO IMPACT TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC.T 5DIFF AUTOLOADER HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other