BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3935840 · Received June 27, 2014

    Report

    Report Number
    3004193489-2014-00052
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K040603
    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: 01/2016. CONTROL SOLUTION LOT # 1030113176. RANGE: 82-127 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. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD NAY SIGNIFICANT FINDINGS BE A RESULT OF THE 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 INTERVENTION. THE CONSUMER REPORTED THAT, "AN INACCURATE HIGH BLOOD GLUCOSE RESULT LED HIM TO THE HOSPITAL." AT 9:04 AM THE CONSUMER PERFORMED A BLOOD GLUCOSE TEST GETTING A RESULT OF 206 MG/DL. IT IS UNKNOWN IF THE CONSUMER ADMINISTERED ANY ORAL OR INSULIN BASED ON THIS RESULT. THE CONSUMER STATED, "AROUND NOONTIME HE WASN'T FEELING WELL AND HIS WIFE CALLED THE EMTS AND BY THE TIME THEY ARRIVE HE WAS UNCONSCIOUS." WHEN THE EMTS PERFORMED A BLOOD GLUCOSE TEST ON THEIR UNKNOWN BRAND OF GLUCOSE METER THEY RECEIVED A RESULT OF 54 MG/DL. THE CONSUMER WAS TREATED WITH GLUCOSE IV AND AN ORAL MED (UNK). HE WAS TRANSFERRED TO (B)(6) BUT WAS NOT TREATED AND WAS RELEASED SEVERAL HOURS LATER. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378038 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020214027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention