BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2072158 · Received April 28, 2011

    Report

    Report Number
    2517506-2011-00074
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K010313
    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 ELEVATED TROPONIN I RESULTS IS UNKNOWN. A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO THE ACCOUNT. THE FSE 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 ELEVATED TROPONIN I RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES. THE RESULTS WERE ACCOMPANIED BY ABNORMAL ASSAY FLAGS. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT SYSTEM AND NEGATIVE RESULTS WERE OBTAINED. PATIENT TREATMENT WAS IN THREE CASES WAS TO ADMINISTER LOVENOX (HEPARIN) OR NITROGLYCERIN. IN ONE INSTANCE, A PATIENT WAS ADMITTED ON THE BASIS OF THE ELEVATED RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FB1285

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization