BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®I 725 SYSTEM

    MDR report key: 2152815 · Received July 7, 2011

    Report

    Report Number
    2122870-2011-02179
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT FOLLOW THE OUTLINED PROCEDURE FOR LOADING A NEW REAGENT PACK ON THE SYSTEM. NO SAMPLE DATA, CENTRIFUGATION, OR CALIBRATION DATA WERE PROVIDED. THROUGH ROUTINE TROUBLESHOOTING WITH CUSTOMER, BEC CUSTOMER TECHNICAL SUPPORT (CTS) DISCOVERED THAT THE REAGENT PACK WAS LOADED IN AN INCORRECT SLOT ON THE REAGENT CAROUSEL. PER CTS INSTRUCTIONS, CUSTOMER REMOVED REAGENT PACK AND DISCARDED IT. USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A TROPONIN I (ACCUTNI) REAGENT PACK MIS-LOAD ON THE SYNCHRON LX I 725 SYSTEM. THE MIS-LOAD LED TO FOUR IND FLAGGED RESULTS ON A TROPONIN I ASSAY. NO RESULTS WERE REPORTED OUT OF THE LAB. THE SYNCHRON LX I 725 SYSTEM FLAGGED THE RESULTS AS "IND" BECAUSE IT DID NOT DETECT REAGENT IN THE REAGENT CAROUSEL. NO PATIENT RESULTS WERE BELIEVED TO BE AFFECTED BY THE MIS-LOADED PACK. THERE ARE NO REPORTS OF PATIENT INJURY OR UNNECESSARY MEDICAL TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX®I 725 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1