BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3233468 · Received July 18, 2013

    Report

    Report Number
    1226181-2013-00323
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE SAMPLE HAD BEEN RERUN ON THE SAME INSTRUMENT AND RESULTED AS EXPECTED. THE TSC SPECIALIST DID DISCOVER THAT THE CUSTOMER WAS NOT CENTRIFUGING PATIENT SAMPLES ACCORDING TO THE TUBE VENDOR SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED SODIUM AND CHLORIDE RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE CAUSE OF THE SAMPLE TUBES 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 AND CHLORIDE RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT, AND THE SODIUM AND CHLORIDE METHODS RESULTED LOWER ON BOTH INSTRUMENTS. THE RERUN RESULTS FROM THE SAME INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED SODIUM AND CHLORIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335141 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1