BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1030279 · Received April 15, 2008

    Report

    Report Number
    1226181-2008-00039
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K9440093
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULTS WAS A LOOSE HM WASH PROBE. THE MALFUNCTION WAS RESOLVED AFTER THE CUSTOMER CORRECTED THE PROBLEM WITH GUIDANCE FROM A SIEMENS HEALTHCARE DIAGNOSTICS, INC TECHNICAL SOLUTION CENTER REPRESENTATIVE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    FALSELY ELELVATED TROPONIN I RESULTS WERE OBTAINED ON 3 PTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED AND NEGATIVE RESULTS WERE OBTAINED. THE PTS WERE ADMITTED TO THE HOSPITAL. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELELVATED TROPONIN RESULTS WAS A LOOSE HM WASH PROBE.

    Additional Manufacturer Narrative · 2

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULTS WAS A LOOSE HM WASH PROBE. THE MALFUNCTION WAS RESOLVED AFTER THE CUSTOMER CORRECTED THE PROBLEM WITH GUIDANCE FROM A SIEMENS HEALTHCARE DIAGNOSTICS, INC TECHNICAL SOLUTION CENTER REPRESENTATIVE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 2

    FALSELY ELELVATED TROPONIN I RESULTS WERE OBTAINED ON 3 PTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED AND NEGATIVE RESULTS WERE OBTAINED. THE PTS WERE ADMITTED TO THE HOSPITAL. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELELVATED TROPONIN RESULTS WAS A LOOSE HM WASH PROBE.

    Additional Manufacturer Narrative · 3

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULTS WAS A LOOSE HM WASH PROBE. THE MALFUNCTION WAS RESOLVED AFTER THE CUSTOMER CORRECTED THE PROBLEM WITH GUIDANCE FROM A SIEMENS HEALTHCARE DIAGNOSTICS, INC TECHNICAL SOLUTION CENTER REPRESENTATIVE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 3

    FALSELY ELELVATED TROPONIN I RESULTS WERE OBTAINED ON 3 PTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED AND NEGATIVE RESULTS WERE OBTAINED. THE PTS WERE ADMITTED TO THE HOSPITAL. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELELVATED TROPONIN RESULTS WAS A LOOSE HM WASH PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. RXLMAXRH NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3