BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2091518 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01582
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FLUSHED THE PROBE AND THE TRANSDUCER BUT THIS DID NOT CORRECT THE PROBLEM. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND CHECKED VACUUM VALVE FOR WASH COLLAR AND FOUND CLOT IN VALVE. FSE REMOVED THE CLOT WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A LEAK FROM THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE COLLAR WASH WHEN THE INSTRUMENT WAS PRIMING. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1