BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM INSTRUMENT

    MDR report key: 4141073 · Received October 3, 2014

    Report

    Report Number
    1226181-2014-00498
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT THE SAMPLE TUBE WAS A SHORT DRAW AND SLIGHTLY HEMOLYZED. CCC INSTRUCTED THE CUSTOMER TO CLEAN WINDOWS AND REPLACE AND ALIGN THE SAMPLE PROBE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING FROM A SMALL SAMPLE CONTAINER ON THE SAME INSTRUMENT. 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 SAMPLE WAS REPEATED FROM A SMALL SAMPLE CONTAINER ON THE SAME INSTRUMENT, RESULTING LOWER. 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 ELEVATED TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619334 DIMENSION RXL MAX WITH HM INSTRUMENT CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1