BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3 DELTA (TOTAL PROTEIN) CLINICAL SYSTEM

    MDR report key: 1190656 · Received October 6, 2008

    Report

    Report Number
    2050012-2008-00057
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K942676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC RUN PRIOR TO THE EVENT WAS WITHIN LAB ESTABLISHED RANGES. CALIBRATIONS HAVE APPEARED NORMAL. PATIENT SAMPLES RUN BEFORE AND AFTER THE EVENT WERE REVIEWED AND RESULTS WERE ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT, AND DISCOVERED THAT BOTH LIGHT PIPES FOR THE MODULE WERE CORRODED DUE TO AGE. THE FSE REPLACED THE LIGHT PIPES, AND THE ANALOG 3 CIRCUIT BOARD. ALTHOUGH THE FSE ADDRESSED HARDWARE ISSUE, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY HIGH CREATININE RESULT THAT WAS GENERATED BY THE SYNCHRON CX3 DELTA CLINICAL SYSTEM FOR A SINGLE PATIENT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR CREATININE AND A RESULT OF 4.2MG/DL WAS REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED LATER AND A RESULT OF 2.62MG/DL WAS OBTAINED. THE CUSTOMER THEN RAN THE SAMPLE ON A DIFFERENT INSTRUMENT IN THEIR LAB AND CREATININE RESULT WAS 2.63MG/DL. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ERRONEOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3 DELTA (TOTAL PROTEIN) CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. CX3 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA