BEUDAMED
    FDA Adverse Event Summary report: N

    NOVAMAX GLUCOSE MONITOR

    MDR report key: 1203498 · Received October 17, 2008

    Report

    Report Number
    3004193489-2008-00601
    Date Received
    October 17, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, ADMINISTERED INSULIN BASED ON THE BLOOD GLUCOSE READINGS SHE RECEIVED ON HER BLOOD GLUCOSE METER, YET EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA. SHE CORRECTED HER BLOOD GLUCOSE BY ADDING TO HER DIET. DURING THE CALL TO CUSTOMER SERVICE, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST, HER TEST STRIPS VIALS AND WAS UNAWARE OF THE REASON FOR ITS USE. THIS PRACTICE IS AGAINST THE DIRECTIONS FOR USE FOR THE DEVICE AND ALSO PREVENTS ESTABLISHING THE INTEGRITY OF A NEW VIAL OF TEST STRIPS BEFORE USE. THE CONSUMER WAS EDUCATED AT THE TIME OF THE ORIGINAL CALL. THE TEST STRIPS USED DURING THE EVENT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020208077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK