BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1070750 · Received June 27, 2008

    Report

    Report Number
    2517506-2008-00056
    Event Type
    Other
    Date Received
    June 27, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATE INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED TROPONIN I RESULT WAS REMOVAL OF THE SAMPLE BEFORE AUTO REPEAT COMPLETED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED TROPONIN I RESULT WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A POSITIVE RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM CTNI FLEX REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA GC9119

    Patients

    Seq Age Sex Outcome Treatment
    1