BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

    MDR report key: 2051024 · Received April 12, 2011

    Report

    Report Number
    2517506-2011-00065
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 IS SAMPLE INTEGRITY. THE IFU FOR THE DIMENSION CTNI FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER." 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 REPORTED TO THE PHYSICIAN. A REDRAW SAMPLE WAS TESTED AND A LOWER RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS 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 CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EB1342

    Patients

    Seq Age Sex Outcome Treatment
    1