BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 6938431 · Received October 10, 2017

    Report

    Report Number
    2517506-2017-00760
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 10, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). A CCC SPECIALIST INSTRUCTED THE CUSTOMER TO RUN PRECISION TESTING WITH 3 DIFFERENT SAMPLES, AND RESULTS WERE SATISFACTORY. THE CCC THEN INSTRUCTED THE CUSTOMER ALIGN THE PUMP AND REPLACE THE INTEGRATED MULTI-SENSOR TECHNOLOGY (IMT) PUMP TUBING. THE CCC SPECIALIST INSTRUCTED THE CUSTOMER TO RUN QUALITY CONTROL (QC) WHICH RESULTED SATISFACTORY. THE CUSTOMER ISSUE WAS NOT RESOLVED. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCH TO THE CUSTOMER SITE. THE CSE REPLACED THE XO TUBING, CLEANED THE ROTARY VALVE AND ALL PORTS. THE CSE REPLACED THE X SEAL. THE CSE ALIGNED THE IMT PUMP TO ENSURE THE PUMP RATE WAS CONSISTENT. THE CSE INSPECTED THE WASTE TUBING AND VERIFIED PROPER EVACUATION OF WASTE AND WAS FREE OF CLOG. THE CSE RAN CONDITION AND DILUTION CHECK. THE CSE REPEATED QC PRECISION, ALL RESULTED ACCEPTABLE. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED INFORMATION PROVIDED AND FOUND NO PRODUCT ISSUE. HOWEVER, IT WAS NOTED THE CUSTOMER IS USING A STAT SPIN, SPINNING FOR 3 MINUTES. STAT SPINS ARE NOT RECOMMENDED BY TUBE VENDOR. THE CUSTOMER SHOULD FOLLOW THE TUBE MANUFACTURER RECOMMENDATIONS FOR PROPER CENTRIFUGATION TIMES AND SPEED. THE CAUSE OF THE SAMPLE BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE CAUSE FOR THE FALSELY ELEVATED NA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME DIMENSION EXL WITH LM 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 NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717256 DIMENSION EXL WITH LM DIMENSION EXL WITH LM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1