BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3242900 · Received July 23, 2013

    Report

    Report Number
    1226181-2013-00337
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LTJ
    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 INITIAL MDR 1226181-2013-00337 WAS FILED ON JULY 23, 2013. ADDITIONAL INFORMATION (07/30/2013): A GLOBAL PRODUCT SUPPORT SPECIALIST REVIEWED THE INSTRUMENT DATA AND DID NOT FIND AN INSTRUMENT MALFUNCTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE SAMPLE WAS REPEATED AND RESULTED HIGHER. THE CAUSE OF THE DISCORDANT, FALSELY LOW TPSA RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND RESULTED HIGHER. IT IS UNKNOWN IF 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 TPSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342889 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER LTJ SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1