BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRO LX20

    MDR report key: 828668 · Received November 3, 2004

    Report

    Report Number
    2050012-2004-00029
    Event Type
    Other
    Date Received
    November 3, 2004
    Date of Event
    September 29, 2004
    Report Date
    November 3, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED COPIES OF THE PT REPORTS AND AN INCOMPLETE COPY OF THE SYNCHRON LX20 SYSTEM EVENT LOG. THE PT'S REPORT WAS REVIEWED BY BECKMAN COULTER. THE TWO SAMPLE IDS IN QUESTION HAVE THE SAME SUFFIX, BUT HAVE A DIFFERENT PREFIX. THE SYNCHRON LX20 EVENT LOG DOES NOT COLLECT THE DEMOGRAPHICS DOWNLOAD BY THE CUSTOMER'S LAB INFO SYSTEM (LIS). IT CANNOT BE DETERMINED IF PT DEMOGRAPHICS ASSOCIATED WITH A PT SAMPLE ID IS REFERENCED BY THE PREFIX, SUFFIX, OR BOTH BY THE CUSTOMER'S LIS. WITHOUT THIS INFO, BECKMAN COULTER INC. IS NOT ABLE TO CONCLUSIVELY DETERMINE IF THE CUSTOMER'S LIS OR THE SYNCHRON LX20 IS THE SOURCE OF THIS ERROR. DUE TO THE LACK OF LIS INFO AND THE INCOMPLETENESS OF THE SYNCHRON LX20 EVENT LOG DATA PROVIDED BY THE CUSTOMER, A MALFUNCTION WILL BE ASSUMED FOR THIS REPORT. THE ROOT CAUSE IS UNKNOWN AND UNKNOWABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER TO INDICATE THE ONE PT REPORT WAS PRINTED WITH THE INCORRECT PT NAME AND PT ID. THE TESTING WAS PERFORMED USING A SYNCHRON LX20 INSTRUMENT. THE CUSTOMER INDICATED THE PT REPORT WAS PRINTED VIA A LABORATORY INFO SYSTEM (LIS). THE CUSTOMER INDICATED THE PT'S NAME AND PT'S ID ON THE REPORT WERE THE NAME AND ID OF A DIFFERENT PT, WHO'S SAMPLE HAD BEEN ASSAYED THE PREVIOUS DAY. THE CUSTOMER INDICATED THE ERROR WAS DETECTED DURING THE REPORT VERIFICATION PROCESS AND THE RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFO REGARDING THIS EVENT. THE CUSTOMER INDICATED THAT THERE HAS BEEN NO CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO LX20 CLINICIAL CHEMISTRY ANALZER JJC BECKMAN COULTER, INC. LX20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other