BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3093846 · Received May 6, 2013

    Report

    Report Number
    1226181-2013-00205
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DID NOT FIND AN INSTRUMENT MALFUNCTION. THE INSTRUMENT WAS DUE FOR PREVENTIVE MAINTENANCE, WHICH THE CSE PERFORMED. THE CSE ALSO PERFORMED A SYSTEM DECONTAMINATION. PATIENT SAMPLES WERE THEN RERUN AND RESULTED AS EXPECTED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS IS UNKNOWN. 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 PATIENT SAMPLES ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE OPERATOR DISCOVERED THAT THE FIRST LEVEL QUALITY CONTROL WAS HIGH. IT IS UNKNOWN IF THE QUALITY CONTROLS WERE WITHIN RANGE WHEN PATIENT SAMPLES WERE RUN. THE OPERATOR RERAN THE PATIENT SAMPLES ON THE SAME INSTRUMENT AFTER SERVICE, AND THE SAMPLES RESULTED LOWER UPON RERUN. IT IS UNKNOWN IF 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 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195873 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1