BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 4257071 · Received November 18, 2014

    Report

    Report Number
    1226181-2014-00594
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER INSTRUMENT AND INSTRUMENT DATA EVALUATION, THE CSE DETERMINED THAT THERE WAS NO INSTRUMENT MALFUNCTION DURING THE TIME OF THE EVENT. THE HEADQUARTERS SUPPORT CENTER DETERMINED THAT THE POTASSIUM SAMPLE WAS PROCESSED PRE-CENTRIFUGED, WHICH INDICATES THE SAMPLE UNDERWENT POOR PRE-ANALYTICAL SAMPLE HANDLING. THE CAUSE OF THE DISCORDANT POTASSIUM RESULT IS UNKNOWN. THE CUSTOMER SUCCESSFULLY REPEATED THE POTASSIUM RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT K RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. THE SAME SAMPLE WAS REPEATED TWO TIMES ON ALTERNATE INSTRUMENTS, BOTH RESULTING LOWER. IT IS UNKNOWN AS TO WHICH REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT K RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745821 DIMENSION VISTA 1500 CLINICAL CHEMISTRY SYSTEM MZV SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1