BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX TEST STRIPS 50'S - 43437

    MDR report key: 1022292 · Received January 24, 2008

    Report

    Report Number
    MW5006093
    Event Type
    Malfunction
    Date Received
    January 24, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 22, 2008
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STRIPS ARE READING ABOUT 20 POINTS 60 POINTS OFF. DOSE, FREQUENCY, AND ROUTE USED: USE 8 TO 10 TIMES DAILY SUB Q. DIAGNOSIS FOR USE: TYPE 1 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX TEST STRIPS 50'S - 43437 NONE NBW NOVA BIOMEDICAL 1020407261

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR MINIMED 10 YRS| HUMALOG 10 YRS