BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1365541 · Received January 16, 2009

    Report

    Report Number
    3004193489-2009-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    January 10, 2009
    Report Date
    January 16, 2009
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL BY A CONSUMER'S CARETAKER THAT THE CONSUMER WAS UNABLE TO TEST HER BLOOD SUGAR BECAUSE THE TEST STRIPS WOULD NOT SIP UP CONTROL SOLUTION OR BLOOD. THE RECENTLY DISCHARGED CONSUMER WAS THEN TAKEN BACK TO THE HOSPITAL. THE INABILITY TO TEST HER BLOOD SUGAR IN AN EMERGENT EVENT MAKES THIS A REPORTABLE EVENT. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020208116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention