BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3070201 · Received April 17, 2013

    Report

    Report Number
    3004193489-2013-00037
    Event Type
    Other
    Date Received
    April 17, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 17, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THAT A CONSUMER RECEIVED A RESULT OF 583 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED 12 UNITS OF INSULIN BASED ON THE RESULT. SUBSEQUENTLY, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT CAUSING HER TO PASS OUT. THE CONSUMER WOKE UP AND HAD EMERGENT FOOD INTAKE TO RAISE HER BLOOD GLUCOSE LEVEL. IT WAS SUGGESTED TO THE CONSUMER TO FOLLOW-UP WITH HER HCP. THE CONSUMER DESCRIBED HERSELF AS A BRITTLE DIABETIC. THE METER AND TEST STRIPS USED DURING THE EVENT WILL BE RETURNED FOR EVALUATION. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166538 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020412255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention