BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER GEN S SYSTEM WITH SOFTWARE V4A.5

    MDR report key: 552190 · Received April 21, 2004

    Report

    Report Number
    1061932-2004-00005
    Event Type
    Other
    Date Received
    April 21, 2004
    Date of Event
    March 24, 2004
    Report Date
    April 21, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, THE GENS INSTRUMENT PRINTED OUT THE INCORRECT PT LAST NAME WITH PT RESULTS. THE INCORRECT PT LAST NAME WAS PRINTED OUT WITH THE CORRECT SAMPLE ID AND PT ID. - THE CUSTOMER DISCOVERED THE MISIDENTIFIED LAST NAME WHEN THE INSTRUMENT PRINTOUT DID NOT MATCH THE LAST NAME ON THE LAB INFO SYSTEM (LIS) COMPUTER. - ALL PT DEMOGRAPHICS MATCHED EXCEPT FOR THE PT'S LAST NAME. THE CUSTOMER'S LAB LIS INTERFANCE USES THE SAMPLE ID AS THE PRIMARY PT IDENTIFIER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. BASED ON THE AVAILABLE INFO REGARDING THIS PT, TREATMENT WAS NOT AFFECTED BY THE MISMATCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other