BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1368072 · Received February 6, 2009

    Report

    Report Number
    1226181-2009-00017
    Event Type
    Malfunction
    Date Received
    February 6, 2009
    Date of Event
    October 25, 2009
    Report Date
    January 25, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 ELEVATED TROPONIN I RESULTS WAS INADEQUATE HM WASH PROBE 1 NOT ASPIRATING. THE FSE CORRECTED THE MALFUNCTION. 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 PT AND QUALITY CONTROL SAMPLES. TWO OF THE PT RESULTS WERE REPORTED TO THE PHYSICIANS. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. IT IS UNKNOWN IF PT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS.

    Additional Manufacturer Narrative · 2

    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 ELEVATED TROPONIN I RESULTS WAS INADEQUATE WAS HM WASH PROBE 1 NOT ASPIRATING. THE FSE CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    MULTIPLE FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON PT AND QUALITY CONTROL SAMPLES. TWO OF THE PT RESULTS WERE REPORTED TO THE PHYSICIANS. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. IT IS UNKNOWN IF PT TREATMENT WAS ALTERED OR PRESCRIBED. 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 CLINICAL CHEMISTRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. RXLMAXHM NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2