BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2011005 · Received March 8, 2011

    Report

    Report Number
    1226181-2011-00021
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 23, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HM CHROM CONTAMINATION. A SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO PERFORM MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THREE FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES IN ONE DAY OF TESTING. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED AND REPORTED. PATIENT TREATMENTS WERE NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE ELEVATED TROPONIN I RESULTS. 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 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD RXL MAX HM

    Patients

    Seq Age Sex Outcome Treatment
    1