BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1061748 · Received June 13, 2008

    Report

    Report Number
    1226181-2008-00063
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 18, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 RESULT WAS SLIPPING HM WASH PUMP DUE TO LACK OF ROUTINE MAINTENANCE BY THE OPERATOR. THE MALFUNCTION WAS RESOLVED AFTER THE CUSTOMER CORRECTED THE PROBLEM WITH GUIDANCE FROM A SIEMENS HEALTHCARE DIAGNOSTICS INC TECHNICAL SOLUTIONS CENTER REPRESENTATIVE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT OF 0.91/0.79 NG/ML WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND A RESULT OF 0.02 NG/ML WAS OBTAINED. THE SAMPLE WAS REPEATED ON AN ALTERNATE ANALYZER AND A RESULT OF 0.04 NG/ML WAS 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 RESULT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS SLIPPING HM WASH PUMP DUE TO LACK OF ROUTINE MAINTENANCE BY THE OPERATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1