BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2072173 · Received April 28, 2011

    Report

    Report Number
    2517506-2011-00075
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS SAMPLE INTEGRITY. THE IFU FOR THE DIMENSION(R) CTNI REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. A REPEAT WAS RUN AND A NEGATIVE WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW CE1312

    Patients

    Seq Age Sex Outcome Treatment
    1