BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2180414 · Received July 27, 2011

    Report

    Report Number
    2517506-2011-00122
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 5, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATES THAT THE CAUSE OF THE FALSE NEGATIVE TROPONIN I RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE NEGATIVE TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. PRIOR RESULTS WERE POSITIVE FOR TROPONIN. THE SAMPLE WAS REPEATED AND POSITIVE RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSE NEGATVE TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM DIMENSION® CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC CB2047

    Patients

    Seq Age Sex Outcome Treatment
    1