BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2072171 · Received April 28, 2011

    Report

    Report Number
    2517506-2011-00072
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K970330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED SODIUM RESULTS WAS UNKNOWN. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT AND PERFORMED MAINTENANCE PROCEDURES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    MULTIPLE FALSELY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND IMMEDIATELY RERUN ON AN ALTERNATE INSTRUMENT SYSTEM. HIGHER RESULTS WITHIN THE NORMAL RANGE WERE OBTAINED AND REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM QUIKLYTE® INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 0MD842

    Patients

    Seq Age Sex Outcome Treatment
    1