BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX20

    MDR report key: 539501 · Received March 19, 2004

    Report

    Report Number
    2050012-2004-00005
    Event Type
    Other
    Date Received
    March 19, 2004
    Date of Event
    February 21, 2004
    Report Date
    March 19, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO OUR CUSTOMER, A FALSELY LOW ETOH (ETHLY ALCOHOL) AND 4 FALSELY LOW AMYLASE RESULTS WERE GENERATED BY THE SYNCHORN LX20. PT A HAD AN ETOH RESULT OF 19.3 MG/DL. PT B HAD AN AMYLASE RESULT OF 16 IU/L. PT C HAD A AMYLASE RESULT OF 112 IU/L. PT D HAD AN AMYLASE RESULT OF 138 IU/L. PT E HAD AN AMYLASE RESULT OF 43 IU/L. THE CUSTOMER INDICATED THAT ALL THE PT SAMPLES REPEATED HIGH (SEE B6) AFTER BEING RETESTED. THE E.R. IS CALLING THE PTS BACK FOR ADDITIONAL EVALUATION. BASED ON THE INFO PROVIDED BY THE CUSTOMER, IT IS NOT KNOWN IF PT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER, INC. LX20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other