BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2073470 · Received May 1, 2011

    Report

    Report Number
    2050012-2011-01124
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN RANGE BEFORE THE EVENT AND LOW AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTICED THE STIRRER WAS NOT TURNING IN THE CUP MODULE. THE FSE REPLACED THE CREATININE MODULE. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRATIC CREATININE (CREM) RESULTS GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM FOR MULTIPLE PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SPECIMENS WERE RE-TESTED AND CORRECT CREM RESULTS WERE OBTAINED. PATIENT RESULTS ARE PROVIDED IN ATTACHED FILE. THERE WAS NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1