BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE METER

    MDR report key: 3810262 · Received April 29, 2014

    Report

    Report Number
    3004193489-2014-00027
    Event Type
    Other
    Date Received
    April 29, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020214027 EXPIRATION DATE: 01/01/2016. 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

    CONSUMER CALLED DUE TO REPORT, "I WAS RECEIVING A BG READING ON MY NOVA MAX METER THAT IS HIGHER THAN THE READING COMPARED TO A COMPETITOR'S METER." IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE CONSUMER PERFORMED A BLOOD GLUCOSE TEST USING HIS NOVA MAX METER GETTING A RESULT OF 139 MG/DL THEN IMMEDIATELY PERFORMED A TEST ON HIS OTHER METER GETTING A RESULT OF 82 MD/DL. SUBSEQUENTLY, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT, WHICH DID NOT REQUIRE MEDICAL INTERVENTION, BUT DID REQUIRE MEDICAL EMERGENT FOOD TO HELP RAISE HIS BLOOD GLUCOSE LEVEL. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256900 NOVA MAX GLUCOSE METER GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020214027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention