BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2949177 · Received February 7, 2013

    Report

    Report Number
    1226181-2013-00069
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). WHILE REVIEWING THE INSTRUMENT DATA WITH THE CUSTOMER, THE TSC SPECIALIST DISCOVERED THAT THE HIGH RESULTS HAD BEEN APPROPRIATELY FLAGGED BY THE INSTRUMENT. ADDITIONALLY, THE RERUN RESULTS HAD BEEN CORRECT AND OTHER PATIENT RESULTS PROCESSED AT THAT TIME WERE CORRECT. BASED ON THESE FACTORS, IT WAS DETERMINED THAT A SERVICE VISIT WAS NOT NECESSARY. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED NA, K, AND CL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ONCE ON THE SAME INSTRUMENT AND ONCE ON AN ALTERNATE DIMENSION VISTA 1500 INSTRUMENT, AND THE RERUN RESULTS MATCHED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED NA, K, AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52187 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1