BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1052142 · Received May 16, 2008

    Report

    Report Number
    1226181-2008-00054
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 18, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION 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 SLIPPING HM WASH PUMP DUE TO LACK OF MONTHLY MAINTENANCE BY THE CUSTOMER. THE MALFUNCTION WAS RESOLVED AFTER THE CUSTOMER CORRECTED THE PROBLEM WITH GUIDANCE FROM A SIEMENS HEALTHCARE DIAGNOSTICS INC TECHNICAL SOLUTIONS CENTER REP. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON FOUR PTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIANS. THE ORIGINAL SAMPLES WERE RETESTED AND NEGATIVE RESULTS WERE OBTAINED. IT IS UNK 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. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULTS WAS A SLIPPING HM WASH PUMP DUE TO LACK OF MONTHLY MAINTENANCE BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1