BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER GEN.S SYSTEM WITH SOFTWARE V4A.5

    MDR report key: 551796 · Received March 30, 2004

    Report

    Report Number
    1061932-2004-00004
    Event Type
    Other
    Date Received
    March 30, 2004
    Date of Event
    February 29, 2004
    Report Date
    March 30, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER, THE GEN.S INSTRUMENT PRINTED OUT THE INCORRECT PT DEMOGRAPHICS WITH PT RESULTS. THE INCORRECT DEMOGRAPHICS WERE PRINTED OUT WITH THE CORRECT SAMPLE ID. AT 6:37 AM, A BLOOD SAMPLE WAS COLLECTED FROM PT A. AT 7:01 AM, A BLOOD SAMPLE WAS COLLECTED FROM AN (OUT) PATIENT B. AT 7:15 AM, THE BLOOD SAMPLE FROM PATIENT A WAS ANALYZED ON THE GEN.S. THE PRINTOUT LISTED THE SAMPLE ID FROM PT A WITH THE CORRECT RESULTS, BUT WITH DEMOGRAPHICS FROM PT B. THE CUSTOMER DETERMINED THAT AN ERROR OCCURRED BASED ON THE KNOWLEDGE THAT THE OUTPATIENT BLOOD SAMPLE HAD NOT ARRIVED IN THE LAB WHEN THE SAMPLE FROM PT A WAS ANALYZED. THE CUSTOMER'S LAB LIS INTERFACE USES THE SAMPLE ID AS THE PRIMARY PT IDENTIFIER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. ACCORDING TO THE CUSTOMER, THE ERRONEOUS RESULT DID NOT AFFECT PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER GEN.S SYSTEM WITH SOFTWARE V4A.5 AUTOMATED CELL COUNTER GKL BECKMAN COULTER, INC. GEN.S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other