BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 8152905 · Received December 11, 2018

    Report

    Report Number
    2517506-2018-00687
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 17, 2018
    Report Date
    December 11, 2018
    Manufacturer
    SIEMENS HEATLHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST ANALYZED THE INSTRUMENT DATA AND RECOMMENDED TO THE CUSTOMER TO PERFORM THE FOLLOWING INTEGRATED MULTISENSOR TECHNOLOGY (IMT) MAINTENANCE: BLEACH VENT AND SAMPLE PORTS 3X, FLUSH WITH HOT WATER 3X, PRIME IMT FLUIDS TIMES 3X, CLEAN IMT PROBE TIP (DIRTY), PRIME IMT AND ALIQUOT PROBES 20X, ALIGN THE IMT MODULE, REPLACE THE IMT SENSOR. MAINTENANCE WAS PERFORMED AND THE IMT CALIBRATION AND QUALITY CONTROLS (QCS) WERE RUN AND PASSED. THE ISSUE WAS RESOLVED BY BLEACHING AND FLUSHING THE IMT MODULE, AND REPLACING THE SENSOR. QC AND SAMPLES TESTS WERE RUN WITH ACCEPTABLE RESULTS. THE CUSTOMER RAN PATIENT COMPARISONS ON THE TWO INSTRUMENTS AND THE RESULTS MATCHED BETWEEN THE INSTRUMENTS. THE INSTRUMENT IS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM (NA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT RESULTING LOWER. THE REPEAT RESULTS FROM THE ALTERNATE INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED NA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992341 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEATLHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1