BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1934889 · Received December 21, 2010

    Report

    Report Number
    2050012-2010-01550
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC PRIOR TO THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGE, BUT IF RUN AFTER THE EVENT (BEFORE CALIBRATION), SHOWS THE SAME SHIFT LOW AS PATIENT SAMPLES. AFTER RECALIBRATION, QC AND PATIENT RESULTS RECOVER HIGHER. SERVICE CONTINUES TO INVESTIGATE THE ROOT CAUSE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT SYNCHRON CX9 ALX ANALYZER INTERMITTENTLY GENERATES FALSE LOW SODIUM (NA) AND CHLORIDE (CL) RESULTS. PER CUSTOMER, THE RESULTS DRIFT LOW IN THE MIDDLE OF A RUN. CUSTOMER INDICATED THAT REPEAT OF THE SAMPLE GIVES RESULTS APPROXIMATELY 4MMOL/L HIGHER, WHICH IS REPORTED. THE CUSTOMER PROVIDED NINE PATIENT PRINTOUTS. OF THE PROVIDED EXAMPLES, NONE OF THE CL DIFFERENCES EXCEEDED ASSAY PRECISION CLAIMS, AND ONLY TWO EXCEEDED NA PRECISION CLAIMS. LOW RESULTS HAVE NOT BEEN REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    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