BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725

    MDR report key: 2183589 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02880
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    July 9, 2009
    Report Date
    July 10, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE OBSERVED AN AIR LEAK ASSOCIATED WITH THE GLUCOSE REAGENT STRAW. THE FSE REPLACED THE LEAKING STRAW AND THEN RECALIBRATED THE SYS. ALTHOUGH A PART WAS REPLACED, A SPECIFIC ROOT CAUSE OF THIS EVENT WAS NOT DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS IS ONE OF TWO MEDWATCH REPORTS AS THE CUSTOMER REPORTED TWO SEPARATE EVENTS OCCURRING ON DIFFERENT DAYS. REFERENCE THE MDR NUMBERS BELOW FOR BOTH ASSOCIATED EVENTS: MDR# 2050012-2011-02880, 02881. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ERRONEOUSLY LOW GLUCOSE RESULT WAS GENERATED BY THE SYNCHRON LXI 725. THE INITIAL RESULT WAS REPORTED OUT OF THE LAB. THE SYSTEM GENERATED CRITICAL RERUN FEATURE WAS TRIGGERED AND THE RESULT WAS WITHIN EXPECTATIONS. THE AMENDED RESULT WAS THEN REPORTED OUT OF THE LAB. THERE WAS NO AFFECT TO THE PTS' CARE OR TREATMENT AS THE SYSTEMS' CRITICAL RERUN FEATURE WAS ENABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 JJE BECKMAN COULTER, INC. MA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LX GLUCOSE 2X2L