BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3851539 · Received June 5, 2014

    Report

    Report Number
    1226181-2014-00304
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MZV
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA, WHICH INDICATED HEMOLYSIS INTERFERENCE ON THE POTASSIUM RESULT. OTHER TESTS ORDERED FOR THE PATIENT WERE NOT RUN DUE TO A SAMPLE PROBE CLOG DETECTED ERROR. HSC CONCLUDED THAT THE CAUSE OF THE DISCORDANT, FALSELY LOW K RESULT IS DUE TO A SAMPLE INTEGRITY ISSUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW K RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329215 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER MZV SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1