BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2832930 · Received November 15, 2012

    Report

    Report Number
    1226181-2012-00126
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SOLUTIONS SPECIALIST WAS CONTACTED BY THE CUSTOMER, WHO ANALYZED THE INSTRUMENT DATA AND INSTRUCTED THE CUSTOMER TO ADJUST THE PUMP RATE, REPLACE THE DEPLETED SALT BRIDGE SOLUTION AND PERFORM MAINTENANCE. QC WAS THEN RUN AND WAS IN RANGE. THE CAUSE OF THE DISCORDANT RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT SODIUM (NA) RESULT WAS REPORTED ON THE XPAND PLUS INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON ANOTHER INSTRUMENT AND THEN ON THE SAME INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW XPAND HM

    Patients

    Seq Age Sex Outcome Treatment
    1