BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3081266 · Received April 26, 2013

    Report

    Report Number
    1226181-2013-00185
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). DURING TROUBLESHOOTING WITH THE CUSTOMER, THE TSC SPECIALIST INSTRUCTED THE CUSTOMER TO OBSERVE THE SAMPLE METERING AND FLUSH SYRINGES. THE CUSTOMER THEN DISCOVERED THAT THE THUMBSCREW OF THE FLUSH SYRINGE HAD FALLEN OFF THE BOTTOM, AND WAS NOT MOVING FLUID PROPERLY. THE TSC SPECIALIST INSTRUCTED THE CUSTOMER TO FIX THE THUMBSCREW, WHICH THE CUSTOMER DID. THE SAMPLER WAS THEN PRIMED, AND THE CUSTOMER RAN A SYSTEM CHECK, WHICH PASSED, AND QC, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED RESULTS WAS A MALFUNCTION OF THE FLUSH SYRINGE. 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 CALCIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE, AND THE AVERAGE OF THE RERUN RESULTS WAS REPORTED TO THE PHYSICIAN(S). FALSELY ELEVATED ENZYMATIC CARBON DIOXIDE (ECO2) RESULTS WERE ALSO OBTAINED ON PATIENT SAMPLES, AND WERE FLAGGED BY THE INSTRUMENT. THE ELEVATED ECO2 RESULTS WERE REPORTED TO THE PHYSICIAN(S). PATIENT RESULTS FOR UREA NITROGEN AND ELECTROLYTES APPEARED TO BE ELEVATED, SO THE OPERATOR RAN QUALITY CONTROLS (QC) FOR ALL ASSAYS WITH ELEVATED RESULTS, AND THE QC WAS OUT OF RANGE FOR ALL ASSAYS TESTED. IT IS UNKNOWN IF THE QUALITY CONTROLS WERE OUT OF RANGE WHEN THE PATIENT SAMPLES WERE RUN. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181137 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1