BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 CHEMISTRY SYSTEM

    MDR report key: 2961967 · Received February 14, 2013

    Report

    Report Number
    9612296-2013-00011
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE WAS DISPATCHED FOR THIS EVENT. NO FURTHER NA ISSUES HAVE BEEN REPORTED AT THIS TIME. CUSTOMER AGREED THAT THE NA CALIBRATION SLOPE SHIFT NOTED ON (B)(6) 2013, WAS THE CAUSE OF THE LOWERED NA RESULTS. FAILURE MODE OF THIS EVENT WAS SHIFTED CALIBRATION SLOPE RECOVERY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LOW SODIUM (NA) RECOVERY ON MULTIPLE PATIENT SAMPLES TESTED ON THE AU480 CHEMISTRY SYSTEM ON (B)(6) 2013. THE CUSTOMER STATED THAT NA WAS CALIBRATED FOR THE DAY AND QC WAS PERFORMED FOR THAT 24 HOUR PERIOD. QC WAS NOTED TO BE WITHIN LABORATORY ACCEPTABLE RANGES, BUT ON THE LOW SIDE. CUSTOMER THEN PROCEEDED TO RUN PATIENT SAMPLES. ON MONDAY, (B)(6) 2013, THE NA DAILY CALIBRATION WAS PERFORMED, AND THE CUSTOMER NOTICED THAT THE CALIBRATION SLOPE AND QC RECOVERY RETURNED TO THE LEVELS PREVIOUSLY NOTED BEFORE THE DROP ON (B)(6) 2013. THE CUSTOMER THEN RERAN ALL THE PATIENT SAMPLES FROM THE (B)(6) 2013 RUN AND DISCOVERED THAT MOST NA RESULTS WERE NOW ABOUT 10 UNITS HIGHER. TWENTY FIVE (25) AMENDED REPORTS WERE ISSUED. PATIENT RESULTS ARE PROVIDED IN FILE ATTACHMENT SECTION OF THIS REPORT. PER THE CUSTOMER, THERE HAVE BEEN NO REPORTS OF ANY EFFECT TO PATIENTS IN CONNECTION TO THE LOW NA RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65456 AU480 CHEMISTRY SYSTEM AU480 CHEMISTRY ANALYZER JGS BECKMAN COULTER AU481-02E WITH ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1