BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725

    MDR report key: 2180958 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02770
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    December 23, 2009
    Report Date
    December 23, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K023049
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE PERFORMED A CUP CLEANING PROCEDURE. NO HARDWARE WAS REPLACED. A SPECIFIC ROOT CAUSE OF THIS EVENT WAS NOT DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO ERRONEOUSLY LOW GLUCOSE RESULTS WERE GENERATED BY THE SYNCHRON LX I 725. THE SYSTEM GENERATED CRITICAL RERUN FEATURE WAS TRIGGERED AND RETURNED RESULTS WITHIN EXPECTATION. THE INITIAL LOW RESULTS WERE NOT REPORTED OUT OF THE LAB. QUALITY CONTROLS WERE WITHIN SPEC PRIOR TO AND AFTER THE EVENT. THERE WAS NO CHANGE TO THE PTS' CARE OR TREATMENT SINCE THE RESULTS WERE NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LX GLUCOSE 2X2L