BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3810304 · Received April 29, 2014

    Report

    Report Number
    3004193489-2014-00030
    Event Type
    Other
    Date Received
    April 29, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 18, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USING HIS 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 METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION. TEST STRIP LOG # 1020213354 EXPIRATION DATE 12/01/2015. 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

    A CONSUMER CALLED IN STATING, "I BELIEVE MY NOVA MAX LINK METER IS NOT READING PROPERLY. I WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE ON SATURDAY. WHILE BEING TRANSPORTED, THE AMBULANCE TECHNICIANS TESTED MY BG USING THE NML AND THEIR METER. MY NOVA MAX LINK READ 100 POINTS HIGHER THAN THE AMBULANCE'S BG MONITOR." IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER USING THEIR UNKNOWN METER GETTING A RESULT OF 36 MG/DL. THE EMTS TESTED THE CONSUMER USING THE NOVA MAX LINK METER GETTING A RESULT OF 135 MG/DL. THE CONSUMER COULD NOT PROVIDE ANY FURTHER INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256901 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020213354

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention