BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2360643 · Received December 6, 2011

    Report

    Report Number
    2050012-2011-08209
    Event Type
    Malfunction
    Date Received
    December 6, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 REPORTING THAT ERRONEOUS LOW SODIUM RESULTS WERE GENERATED FOR TWO PATIENT SAMPLES ON THE OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER. CUSTOMER PROVIDED A VERBAL EXAMPLE OF 128 MMOL/L OF NA AND A RERUN OF 144 MMOL/L OF NA FOR ONE PATIENT SAMPLE. THE SECOND PATIENT GAVE A RESULT OF 118 MMOL/L OF NA AND A RERUN OF 132 MMOL/L OF NA. CUSTOMER NOTED THAT QC HAS BEEN LOW ALTHOUGH STILL WITHIN ESTABLISHED RANGES. CUSTOMER DID NOT KNOW WHEN THE ELECTRODE, REAGENTS AND BUFFER SYRINGE WERE LAST REPLACED CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED CUSTOMER TO DATE REAGENTS AND KEEP A RECORD OF WHEN MAINTENANCE WAS DONE. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND FOUND OBSTRUCTION (GEL) IN THE ISE TUBING. FSE PROCEEDED TO REPLACE THE TUBING, RAN CALIBRATION AND QC, VERIFIED REPAIR AND PERFORMANCE WAS WITHIN PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMA K.K. AU400

    Patients

    Seq Age Sex Outcome Treatment
    1