BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3772772 · Received March 3, 2014

    Report

    Report Number
    3004193489-2014-00017
    Event Type
    Other
    Date Received
    March 3, 2014
    Report Date
    February 25, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020313213, EXP DATE: 08/2015. CONTROL SOLUTION LOT: 1030313121 RANGE: 87-127 MG/DL. 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. 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 ON (B)(6) 2014 BY THE CONSUMER'S HUSBAND THAT, "TWO WEEKS AGO HIS WIFE RECEIVED A FALSE READING OF 110 MG/DL AND PASSED OUT FROM BEING VERY LOW AND THE PARAMEDICS HAD TO BE CALLED". DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER'S HUSBAND DECLINED TO PROVIDE ANY FURTHER INFO REGARDING THE REPORTED EVENT. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128412 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020313213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention