BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1993349 · Received February 4, 2011

    Report

    Report Number
    3004193489-2011-00013
    Event Type
    Other
    Date Received
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 VIA EMAIL, THAT SOMETIME IN (B)(6) 2011, THAT THE CONSUMER RECEIVED A RESULT OF 117 MG/DL ON HIS BLOOD GLUCOSE METER. ACCORDING TO THE CONSUMER HE DID NOT BELIEVE THAT RESULT TO BE ACCURATE. EVEN THOUGH THE CONSUMER WAS EXPERIENCING LOW SYMPTOM HE ADMINISTERED AN UNK AMOUNT OF INSULIN AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT. THE CONSUMER DID NOT REPORT IF HE REQUIRED ANY MEDICAL OR EMERGENT FOOD INTERVENTION. IT IS UNK IF THE CONSUMER PERFORMED A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE OF THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. CUSTOMER SERVICE CONTACTED THE CONSUMER VIA EMAIL FOR ADDITIONAL INFO AND ASSISTANCE WITH THE NOVA BIOMEDICAL PRODUCTS, HOWEVER, THE CONSUMER HAS YET TO RESPOND BACK TO CUSTOMER SERVICE. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK