BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1823165 · Received September 1, 2010

    Report

    Report Number
    1226181-2010-00117
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 RESULT WAS THE CHEM WASH LINE WAS NOT CONNECTED TO THE WASH PROBE. THE CUSTOMER CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FOUR FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. ONE PATIENT RECEIVED A CARDIAC CATHETERIZATION. 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® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS INC RXLMAXHM

    Patients

    Seq Age Sex Outcome Treatment
    1