BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 2924104 · Received January 22, 2013

    Report

    Report Number
    1226181-2013-00029
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 30, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SOLUTIONS CENTER (TSC). THE TSC ANALYZED THE INFORMATION AND DETERMINED THAT THE CAUSE OF THE EVENT IS UNKNOWN. THE TSC INSTRUCTED THE CUSTOMER TO REPLACE THE SAMPLE PROBE 1 AND REAGENT PROBE 1, CLEAN THE SERVER 1 DRAINS AND PERFORM MONTHLY MAINTENANCE. THE CUSTOMER THEN RAN QUALITY CONTROLS AND A PRECISION TEST. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW MAGNESIUM (MG) RESULT WAS GENERATED BY THE DIMENSION VISTA 1500 SYSTEM FOR A SINGLE PATIENT SAMPLE. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON A DIFFERENT SYSTEM AND THE SAME SYSTEM AND BOTH RESULTS WERE WITHIN EXPECTATIONS. THE RESULT OF THE RETEST WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT MAGNESIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30139 DIMENSION VISTA 1500 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1