BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 2874352 · Received December 14, 2012

    Report

    Report Number
    1226181-2012-00156
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE DISCORDANT NA AND CL RESULTS WAS A MALFUNCTION OF THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PUMP. THE FSE REPLACED THE IMT PUMP, IMT SENSOR, A ROTARY VALVE AND IMT TUBING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR SODIUM (NA) AND CHLORIDE (CL) WERE OBTAINED ON A DIMENSION RXL MAX INSTRUMENT. THE CUSTOMER COMPARED RESULTS BETWEEN TWO INSTRUMENTS IN THE LABORATORY AND DETECTED THAT THE RESULTS WERE HIGH. THE CUSTOMER RERAN ALL THE SAMPLES ON AN ALTERNATE INSTRUMENT AND CORRECTED REPORTS WERE SENT TO THE PHYSICIAN(S).THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM 2JD867

    Patients

    Seq Age Sex Outcome Treatment
    1