BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1220244 · Received October 31, 2008

    Report

    Report Number
    3004193489-2008-00611
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 31, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 593 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED AN UNK AMOUNT OF INSULIN AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT, WHICH DID NOT REQUIRE MEDICAL INTERVENTION. DURING THE CALL, IT WAS REVEALED THAT THE CONSUMER IMPROPERLY STORES THEIR TEST STRIPS. THE CONSUMER WAS EDUCATION TOOK PLACE AT THE TIME OF CALL. IT WAS ALSO REVEALED DURING THE CALL TO CUSTOMER SUPPORT, THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST BEFORE USING THEIR INITIAL TEST STRIPS, AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020207213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK