BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2133916 · Received June 20, 2011

    Report

    Report Number
    2517506-2011-00111
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 13, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    NBC
    PMA / PMN Number
    K071767
    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 PBNP RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED PBNP RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RERUN AS WELL AS AN ADDITIONAL TUBE FROM THE ORIGINAL DRAW. NEGATIVE RESULTS WERE OBTAINED ON BOTH. THE PATIENT WAS ADMITTED AND RECEIVED LASIX TREATMENT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED PBNP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE FLEX® REAGENT CARTRIDGE NBC SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FB2038

    Patients

    Seq Age Sex Outcome Treatment
    1