BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 4132580 · Received October 1, 2014

    Report

    Report Number
    1226181-2014-00492
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    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 CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER PERFORMED A PATIENT LOOK BACK, AND ALL OTHER SAMPLES REPEATED AS EXPECTED. QUALITY CONTROLS WERE WITHIN RANGE AT THE TIME OF EVENT. THE CUSTOMER STATED THAT THE INTRAVENOUS TEAM TOLD THE LABORATORY THEY BELIEVED THE SAMPLE HAD BEEN INCORRECTLY DRAWN. A NEW SAMPLE OBTAINED FROM THE PATIENT RESULTED AS EXPECTED WHEN REPEATED ON THE SAME INSTRUMENT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED VANCOMYCIN 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 VANCOMYCIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE MEAN OF THE DISCORDANT RESULTS WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON ANOTHER DIMENSION VISTA 1500 INSTRUMENT (DV310675) AND ON THE SAME INSTRUMENT (DV310687), RESULTING LOWER BUT DISCORDANT. A NEW SAMPLE WAS OBTAINED AND TESTED ON BOTH INSTRUMENTS (DV310675 & DV310687), RESULTING LOWER AS EXPECTED. THE MEAN OF THE NEW SAMPLE RESULTS WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED VANCOMYCIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610658 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1