BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1971763 · Received January 27, 2011

    Report

    Report Number
    2050012-2011-00253
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS SUCCESSFUL. QC AFTER THE EVENT FAILED WITH ELEVATED RESULTS ON LEVEL 3. GLUCOSE RE-CALIBRATION AFTER THE EVENT FAILED. THE LAST SUCCESSFUL CALIBRATION WAS ON (B)(4) 2010. BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENT WITH ANOTHER CARTRIDGE OF THE SAME LOT AND ALL QC AND PRECISION TEST MET THE ESTABLISHED SPECIFICATIONS. THE ROOT CAUSE FOR THIS EVENT APPEARS TO BE THE REAGENT CARTRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW GLUCOSE (GLU) RESULTS GENERATED BY SYNCHRON LX I 725 CLINICAL SYSTEM FOR TWO PATIENTS WHILE RUNNING IN DUPLICATES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTS ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED HIGHER RESULTS. THERE WAS NO EFFECT TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1