BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1884181 · Received October 15, 2010

    Report

    Report Number
    3004193489-2010-00231
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 15, 2010
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER'S SPOUSE FOUND THE CONSUMER IN BED UNRESPONSIVE. HE TESTED THE CONSUMER GETTING A RESULT OF 297 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER'S SPOUSE ADMINISTERED 4.4 UNITS OF INSULIN BASED ON THAT RESULT. SUBSEQUENTLY, THE USER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. WHEN THE EMT'S ARRIVED THEY TESTED THE CONSUMER USING THEIR UNK BLOOD GLUCOSE METER GETTING A RESULT OF "LO". CONSUMER WAS TRANSPORT TO ER FOR EMERGENT FOOT TREATMENT. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF THE CALL. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020209082

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention