BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX20PRO

    MDR report key: 678186 · Received February 15, 2006

    Report

    Report Number
    2050012-2006-00006
    Event Type
    Other
    Date Received
    February 15, 2006
    Date of Event
    January 24, 2006
    Report Date
    February 15, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING LOW RESULTS FOR CARTRIDGE CHEMISTRIES GENERATED BY THE SYNCHRON LX20PRO INSTRUMENT. THE CUSTOMER INDICATED THAT APPROX AT 5:00 AM VERY LOW RESULTS WERE OBSERVED FOR MAGNESIUM AND TBL. THE CUSTOMER THEN VERIFIED ALL RESULTS TESTED SINCE 4:00 AM AND CORRECTED RESULTS FOR CK AND LDH. CK; THE INITIAL RESULT WAS 61U/L AND 66U/L UPON REPEAT. LDH; THE INITIAL RESULT WAS40U/L AND 191U/L UPON REPEAT. IT IS UNK HOW MANY PT SAMPLES WERE EFFECTED. THE CUSTOMER INDICATED THAT THE LOW RESULTS WERE NOT REPORTED OUT OF THE LAB. BASED ON AVAILABLE INFO, NO TREATMENT WAS INITIATED OR WITHHELD AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20PRO CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER, INC. LX20PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA