BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1182454 · Received September 12, 2008

    Report

    Report Number
    3004193489-2008-00551
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 12, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 361 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN VIA THE PUMP BASED ON THAT READING. ACCORDING TO THE CONSUMER, APPROXIMATELY 10-15 MINUTES LATER, THE CONSUMER REPORTED HE EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. WHEN THE EMT'S ARRIVED THEY TESTED THE CONSUMER USING THEIR BLOOD GLUCOSE METER GETTING A RESULT OF 45 MG/DL AND THEN TESTED HIM USING THE NOVA METER GETTING A RESULT OF 384 MG/DL. 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 AT THE TIME OF THE CALL. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020207285

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK