BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL WITH HM

    MDR report key: 3191415 · Received June 26, 2013

    Report

    Report Number
    1226181-2013-00284
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INSTRUCTED THE CUSTOMER TO ADJUST THE PRESSURE FOOT AND ALIGN THE PUMP. THE CUSTOMER RAN QUALITY CONTROLS (QC) AND PERFORMED A CONDITION AND DILUENT CHECK . QC WAS THEN IN RANGE. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND A LEAK AND SPILL ON TOP OF THE ROTARY VALVE, CLEANED SEALES ON MONO AND ROTARY VALVE, STYLETTED AND LUBRICATED ALL CONNECTIONS, REPLACED TUBING, STYLETTED AND ALIGNED PROBE. INSTRUMENT FULLY FUNCTIONAL ON FSE DEPARTURE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED SODIUM RESULT IS UNKNOWN. THE CAUSE OF THE SAMPLES BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL WITH HM INSTRUMENT. THE PATIENT SAMPLE WAS RERUN IN DUPLICATE ON THE SAME INSTRUMENT AND BOTH RESULTED LOWER. NO RESULTS WERE RELEASED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289997 DIMENSION RXL WITH HM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1