BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2840304 · Received November 20, 2012

    Report

    Report Number
    2517506-2012-00309
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JJE
    PMA / PMN Number
    K860021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 UREA NITROGEN RESULTS IS UNKNOWN. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO ROUTINE TROUBLESHOOTING MEASURES AND REPLACEMENT OF THE REAGENT CARTRIDGE WELL WHICH RESOLVED THE QC AND PATIENT SAMPLE ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY DEPRESSED UREA NITROGEN (BUN) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AFTER QC RESULTS WERE FOUND TO BE OUT OF RANGE DEPRESSED. HIGHER REPEAT RESULTS WERE OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED UREA NITROGEN (BUN) RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DEPRESSED UREA NITROGEN (BUN) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM UREA NITROGEN FLEX® REAGENT CARTRIDGE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1