BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1342835 · Received March 13, 2009

    Report

    Report Number
    2050012-2009-00035
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 13, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN LAB ESTABLISHED RANGES. NO OTHER QUESTIONABLE CRE3 RESULTS WERE FOUND. A FIELD SERVICE ENGINEER WAS DISPATCHED: THE FSE PERFORMED MAINTENANCE ON THE CUP AND VERIFIED PERFORMANCE. AS OF 2009, NO FURTHER EVENTS HAVE BEEN REPORTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER TESTED PATIENT SAMPLE FOR CREATININE (CRE3) AND A RESULT OF 0.9MG/DL WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-TESTED AND REPEATED CRE3 RESULT WAS 1.4MG/DL. IN ADDITION, THE ORIGINAL SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND CRE3 RESULT OF 1.5MG/DL WAS OBTAINED. THE CRE3 RESULT WAS AMENDED. 6. IT IS UNKNOWN IF PATIENT TREATMENT WAS INITIATED OR WITHHELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1