BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5CE CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1962208 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00179
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K926060
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, CONTROLS RUN AFTER THE SET POINT MODIFICATION RECOVERED OUT OF RANGE HIGH. CONTROLS RUN AFTER THE SET POINT WAS CORRECTED RECOVERED WITHIN RANGE AND CALIBRATION WAS ACCEPTABLE. NO SERVICE WAS REQUIRED FOR THIS EVENT, AS THE CUSTOMER RESOLVED THE ISSUE BY ENTERING THE SET POINT CORRECTLY.

    Description of Event or Problem · 1

    PER THE CUSTOMER LETTER SENT FROM BCI, DATED ON (B)(4) 2010, WHICH CALLED FOR ADJUSTING THE CALIBRATOR SET POINT FOR TG IN CALIBRATOR ONE (1) TO A HIGH VALUE. THE CUSTOMER INCORRECTLY ADJUSTED THE CALIBRATOR ZERO (0) FOR TRIGLYCERIDE (TG) TO A HIGH VALUE INSTEAD OF ADJUSTING CALIBRATOR ONE (1) TO A HIGH VALUE ON THE SYNCHRON CX5CE CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT NONE OF THE PHYSICIANS HAD ACTED ON THE FALSELY REPORTED RESULTS, SO NO CHANGE IN PATIENT THERAPY WAS GIVEN AS A RESULT OF THE ORIGINAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5CE CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 CE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1