BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3191504 · Received June 26, 2013

    Report

    Report Number
    1226181-2013-00285
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE R1 PROBE, CHECK THE DEPTH ALIGNMENT OF THE PROBE, AND CLEAN THE SAMPLE PROBE AND SAMPLE PROBE DRAIN. THE CUSTOMER PERFORMED THIS MAINTENANCE AND STATED THAT THE SAMPLE PROBE DRAIN WAS DIRTY AND THAT THE R1 PROBE ALIGNMENT HAD NEEDED TO BE LOWERED. THE TSC SPECIALIST FOLLOWED UP WITH THE CUSTOMER, AND THE CUSTOMER HAD NOT HAD ANY FURTHER ISSUES WITH RESULTS ON THE DIMENSION RXL MAX INSTRUMENT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN LATER IN THE DAY, AND THE NEW SAMPLE RESULTED LOWER THAN THE INITIAL SAMPLE UPON TESTING ON THE SAME INSTRUMENT. THE PHYSICIAN(S) QUESTIONED THE INITIAL SAMPLE RESULT, AND THE INITIAL SAMPLE WAS RERUN AND ALSO RESULTED LOWER. THE RERUN RESULT 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
    290051 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1