BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3183043 · Received June 21, 2013

    Report

    Report Number
    1226181-2013-00274
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 15, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 CONDITION THE INTEGRATED MULTISENSOR TECHNOLOGY SYSTEM AND THEN REPEAT QUALITY CONTROLS (QC). QC WAS THEN IN RANGE. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM AND POTASSIUM RESULTS 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 LOW SODIUM AND POTASSIUM RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. ONE OF THE PATIENT'S DISCORDANT RESULTS WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE DISCORDANT RESULTS OF THE SECOND PATIENT WERE NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPEATED ON ANOTHER DIMENSION EXL WITH LM INSTRUMENT AND BOTH SODIUM AND POTASSIUM RESULTED HIGHER. 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 LOW SODIUM AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283686 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1