BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 2991450 · Received March 6, 2013

    Report

    Report Number
    1226181-2013-00112
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND THE INSTRUMENT DATA, THE FSE DISCOVERED THAT THE SAMPLE TUBING AND THE WATER SUPPLY TUBING WERE DAMAGED, THE SAMPLER AND REAGENT 1 (R1) TUBING CONNECTIONS WERE MISFITTED, AND THE R1 PROBE, SAMPLE PROBE, AND WASH PROBES WERE MISALIGNED. THE FSE REPAIRED THE SAMPLE TUBING, REPLACED THE WATER SUPPLY TUBING, CORRECTED THE SAMPLER AND R1 TUBING CONNECTIONS, AND REALIGNED ALL MISALIGNED PROBES. THE FSE ALSO REPLACED THE REAGENT 2 PROBE TIP, ALIGNED THE PHOTOMETER, AND CLEANED THE WINDOWS. CALIBRATION, QUALITY CONTROLS, AND PRECISION WERE RUN BY THE FSE FOR TROPONIN, AND ALL WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT 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 A PATIENT SAMPLE FROM ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN TRIPLICATE, AND THE CORRECTED 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
    95710 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1