BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND WITH HM

    MDR report key: 4443760 · Received January 22, 2015

    Report

    Report Number
    1226181-2015-00046
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA AND INSTRUCTED THE CUSTOMER TO CLEAN THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PORT AND TO CLEAN THE IMT TUBING. THE HSC ALSO INSTRUCTED THE CUSTOMER TO PERFORM A SYSTEM DILUENT CHECK. THE CUSTOMER SUCCESSFULLY RAN QUALITY CONTROLS. THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND CHLORIDE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION XPAND WITH HM INSTRUMENT. THE INITIAL NA, K AND CL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE CUSTOMER DID NOT PROVIDE CORRECTED NA, K AND CL RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52837 DIMENSION XPAND WITH HM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION XPAND WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1