BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3942479 · Received July 17, 2014

    Report

    Report Number
    1226181-2014-00378
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER STATED THAT THE SAMPLE WHICH RESULTED FALSELY HIGH WAS VISIBLY HEMOLYSED. OTHER SAMPLES OBTAINED FROM THE PATIENT RESULTED AS EXPECTED UPON REPEAT TESTING ON THE SAME INSTRUMENT. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS IS SAMPLE INTEGRITY. THE CAUSE OF THE SAMPLE BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT AS IT DID NOT MATCH THE RESULT FROM A PREVIOUS DRAW. A NEW SAMPLE OBTAINED FROM THE PATIENT WAS TESTED ON THE SAME INSTRUMENT, RESULTING LOWER. THE SAMPLE WHICH THE DISCORDANT RESULT WAS OBTAINED ON WAS THEN REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER THAN THE FIRST RESULT PRODUCED BUT STILL FALSELY ELEVATED . THE CORRECTED RESULT FROM THE NEW SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418566 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1