BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750

    MDR report key: 591607 · Received April 13, 2005

    Report

    Report Number
    1061932-2005-00014
    Event Type
    Other
    Date Received
    April 13, 2005
    Date of Event
    February 21, 2005
    Report Date
    April 13, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING A POSSIBLE SAMPLE MISIDENTIFICATION WHEN RUNNNING PT SAMPLE ON COULTER LH 750 INSTRUMENT IN 2005. THE RESULTS FOR PT A WERE PRINTED WITH PT B DEMOGRAPHICS. THE CUSTOMER INDICATED THAT THE SAMPLE OF PT B WAS TESTED ON THIS INSTRUMENT IN THE PAST (12/04) WITH THE SAME ID AS PT A. THE MISIDENTIFICATION WAS NOTED BY THE CUSTOMER DURING SAMPLE A COMPARISON WITH THE LAB INFORMATION SYSTEM (LIS) COMPUTER DATA. THE CUSTOMER INDICATED THAT SAMPLE IDS ARE RE-CYCLED EVERY 8 WEEKS, BUT IDS ARE NEVER RE-CYCLED IN THEIR LAB. THE CUSTOMER INDICATED THAT THE AUTO-DELETE OPTION WAS ENABLED AT THE TIME OF THIS EVENT. IT WAS SET TO DELETE AUTOMATICALLY, EVERY 24 HOURS, ALL SAMPLES FROM A TO DO LIST ENTRY AND ALL COMPLETED SAMPLES. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT. THE CUSTOMER INDICATED THAT THERE HAS BEEN NO CHANGE TO PT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKH BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other