BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1182450 · Received September 12, 2008

    Report

    Report Number
    3004193489-2008-00558
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 12, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED A RESULT OF 578 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER'S MOM ADMINISTERED WITH UNKNOWN AMOUNT OF INSULIN. APPROXIMATELY TWENTY MINUTES LATER THE PARENT PERFORMED ANOTHER TEST ON THE CONSUMER GETTING A RESULT OF 565 MG/DL. THE CONSUMER'S PARENT DID NOT BELIEVE THAT READING TO BE ACCURATE. THE CONSUMER DID NOT EXPERIENCE A HYPOGLYCEMIC EVENT. THE CONSUMER'S PARENT GAVE THE CONSUMER FOOD AND SOMETHING TO DRINK TO OFFSET THE INSULIN ADMINISTERED. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST THEIR TEST STRIPS BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE. THE METER AND THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020208042

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK