BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2478026 · Received March 5, 2012

    Report

    Report Number
    2517506-2012-00037
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 8, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED TROPONIN I RESULT WAS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS FILED THE ORIGINAL MDR 2517506-2012-00037 ON (B)(4) 2012, AS CAUSE UNKNOWN NEW INFORMATION WAS PROVIDED BY THE SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) ON (B)(4) 2012: ADDITIONAL INFORMATION NOTED AFTER INITIAL MDR FILING: A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO THE ACCOUNT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED TROPONIN I RESULT WAS MULTIPLE MECHANICAL ISSUES. THE FSE PERFORMED APPROPRIATE REPAIR PROCEDURES, INCLUDING VALVE REPLACEMENTS. AFTER REPAIR PROCEDURES, THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE WAS REQUIRED. AN ADDITIONAL MDR WILL BE SUBMITTED AS 1226181-2012-00025 REFLECTING THE REVISED ROOT CAUSE INFORMATION IMPLICATING INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. REPEAT RUNS OF THE SAME SAMPLE RECOVERED AN EXPECTED ELEVATED RESULT. 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 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 DB2208

    Patients

    Seq Age Sex Outcome Treatment
    1