BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PROFILE M MGH SENSOR

    MDR report key: 486714 · Received September 30, 2003

    Report

    Report Number
    1219029-2003-00002
    Event Type
    Malfunction
    Date Received
    September 30, 2003
    Date of Event
    May 6, 2003
    Report Date
    September 29, 2003
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CFA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GENERAL MGR REPORTS THAT HOSP USING A STAT PROFILE M ANALYZER FOUND RECOVERY OF MG++ RESULTS OF PTS LOWER THAN A NOVA 8. THE AVERAGE LEVEL BY NOVA 8 WAS 0.52 MMOL/2 VS 0.35 MMOL/L ON STAT PROFILE M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT PROFILE M MGH SENSOR IONIZED MAGNESIUM SENSOR CFA NOVA BIOMEDICAL I MAGNESIUM ELECTRODE 207152

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN