BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1182424 · Received September 12, 2008

    Report

    Report Number
    2050012-2008-00054
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 12, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC WAS IN RANGE. THE SAMPLES WERE COLLECTED IN RED TOP SST TUBES. THE CUSTOMER DID REVIEW ALL OTHER PHY RESULTS THAT DAY, BUT THERE WERE NO OTHER SAMPLES IN THE RANGE OF 15UG/ML, AND CUSTOMER DOES NOT BELIEVE THERE WAS A SAMPLE MIX-UP. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB AS IT WAS AN ISOLATED, SAMPLE SPECIFIC EVENT. 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 A FALSE LOW PHENYTOIN (PHY) RESULT THAT WAS GENERATED BY THE SYNCHRON CX9 ALX INSTRUMENT. THE INITIAL PHY RESULT OF 15UG/ML WAS REPORTED OUT OF THE LAB. THE PATIENT RECEIVED REGULAR DOSE OF MEDICATION THAT EVENING. THE NEXT DAY, A FRESH SAMPLE FROM THIS PATIENT GAVE A RESULT OF 39UG/ML WHEN TESTED FOR PHY. THE CUSTOMER THEN REPEATED THE ORIGINAL SAMPLE AND A RESULT OF 22UG/ML WAS OBTAINED. AN AMENDED REPORT WAS SENT. DOSAGE WAS CONTINUED BASED UPON THE FALSE LOW PHY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. CX9 ALX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA