BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1070752 · Received June 27, 2008

    Report

    Report Number
    2517506-2008-00055
    Event Type
    Other
    Date Received
    June 27, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS SAMPLE INTEGRITY. THE IFU FOR DIMENSION CTNI FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFO: "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER TO PREVENT APPEARANCE OF FIBRIN IN SERUM SAMPLES, COMPLETE CLOT FORMATION SHOULD TAKE PLACE BEFORE CENTRIFUGATION." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ALTERNATE ANALYZER AND A NEGATIVE RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED 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 FA9076

    Patients

    Seq Age Sex Outcome Treatment
    1