BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3253088 · Received July 29, 2013

    Report

    Report Number
    1226181-2013-00344
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA. AFTER EVALUATION OF THE INSTRUMENT DATA, THE GPS SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE SAMPLE HAD BEEN REPEATED ON THE SAME INSTRUMENT AND RESULTED AS EXPECTED TWICE. 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 SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED LOWER. THE SAMPLE WAS THEN CENTRIFUGED AND RERUN ON THE SAME INSTRUMENT AND RESULTED LOWER. THE RERUN RESULTS WERE 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
    352117 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