BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION (R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2011007 · Received March 8, 2011

    Report

    Report Number
    2517506-2011-00039
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 IS SAMPLE INTEGRITY. THE IFU FOR DIMENSION CTNI FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "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 PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED AND REPORTED. 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 (R) CLINICAL CHEMISTRY SYSTEM TROPONIN I FLEX(R) REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FB1292

    Patients

    Seq Age Sex Outcome Treatment
    1