BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1031476 · Received April 18, 2008

    Report

    Report Number
    3004193489-2008-00381
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 18, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. 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 "HI" (GREATER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER TREATED THE HIGH RESULT WITH 10 UNITS OF INSULIN ALTHOUGH THE CONSUMER REPORTED SHE DID NOT FEEL LIKE SHE'S ON THE HIGH SIDE. SHE FELT MORE LIKE SHE WAS EXPERIENCING A LOW BLOOD SUGAR AND DECIDED TO HAVE SOME JUICE AND THEN THE CONSUMER TOOK A NAP. TWO HRS LATER, THE CONSUMER'S SPOUSE CALLED FOR MEDICAL INTERVENTION BECAUSE THE CONSUMER WAS NOT RESPONSIVE. THE EMTS ARRIVED AND TESTED THIS CONSUMER, GETTING A RESULT OF 23 MG/DL ON THEIR UNK BLOOD GLUCOSE METER. THE EMTS ADMINISTERED AN IV SHOT OF DEXTROSE 50M. THE CONSUMER DECLINED TO BE TRANSFERRED TO THE HOSP. THE METER 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 CORP NA 1020208031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK