BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM INSTRUMENT

    MDR report key: 4662238 · Received April 6, 2015

    Report

    Report Number
    1226181-2015-00181
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 12, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE LYTES SENSOR, INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PUMP ROLLERS, IMT WASH STATION, ROTARY VALVE, IMT TUBING KIT, AND IMT PROBE. THE CSE CHECKED THE ALIGNMENTS AND PUMP RATE AND RAN A CONDITION AND DILUENT CHECK. QUALITY CONTROLS AND PATIENT SAMPLES WERE RUN AND COMPARED WITH THE ALTERNATE DIMENSION RXL INSTRUMENT, ALL OF WHICH RESULTED WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA, K AND CL RESULTS IS UNKNOWN. 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 (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL MAX WITH HM INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION RXL INSTRUMENT, RESULTING HIGHER FOR NA, K AND CL. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIANS(S) THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225053 DIMENSION RXL MAX WITH HM INSTRUMENT CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1