BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 4433146 · Received January 13, 2015

    Report

    Report Number
    3004193489-2015-00002
    Event Type
    Other
    Date Received
    January 13, 2015
    Date of Event
    January 2, 2015
    Report Date
    January 3, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020214149, EXPIRATION DATE: 05/2016, CONTROL SOLUTION LOT # NONE. NOVA MAX TEST STRIP INSERT - QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. 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 EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL AND EMERGENT FOOD INTERVENTION. EMTS WERE CALLED AND THE CONSUMER WAS TRANSPORTED TO THE HOSPITAL WITH LOW BLOOD SUGAR RESULTS AND WAS TREATED AND RELEASED. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID CONTROL SOLUTION TEST THEIR TEST STRIPS FOR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. PRIOR TO THE EVENT, THE CONSUMER WAS EXPERIENCING LOW BLOOD GLUCOSE RESULTS ON HIS NOVA MAX LINK METER. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30015 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020214149

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R