BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3843715 · Received March 25, 2014

    Report

    Report Number
    3004193489-2014-00021
    Event Type
    Other
    Date Received
    March 25, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 17, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT NUMBER 1020213252, EXPIRATION DATE: 09/2015. 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 THE CONSUMER "HAD TO CALL 911 DUE TO HIS HIGH METER READINGS." CONSUMER REPORTED THAT BASED ON HIGHER THAN EXPECTED RESULTS HE RECEIVED THROUGHOUT THE DAY, HE ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. PARAMEDICS PERFORMED A GLUCOSE TEST USING THEIR UNKNOWN EQUIPMENT GETTING A RESULT OF 16 MG/DL. THE CONSUMER WAS TREATED AT HOME WITH IV FLUIDS AND A CARDIOGRAM. CONSUMER DECLINED TRANSPORTATION TO THE HOSPITAL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USING THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. WHILE ON THE PHONE, A CONTROL SOLUTION COULD NOT BE PERFORMED BECAUSE THE CONSUMER DID NOT HAVE ANY NOVA MAX CONTROL SOLUTION. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174042 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020213252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention