BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1012725 · Received March 11, 2008

    Report

    Report Number
    3004193489-2008-00280
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 11, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BLOOD GLUCOSE RESULT OF 256 MG/DL. BASED ON THAT RESULT, THE CONSUMER ADMINISTERED 18 UNITS OF INSULIN AT 11:16 PM AND THEN WENT TO BED. AT 2:15 AM, THE CONSUMER'S SPOUSE CALLED THE EMTS BECAUSE SHE SAID "HE WAS JERKING". THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT WHICH REQUIRED MEDICAL INTERVENTION. THE CONSUMER'S SPOUSE TESTED THE CONSUMER GETTING A RESULT OF 200 MG/DL AT 2:31 AM BEFORE THE EMTS ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY TESTED THE CONSUMER GETTING A RESULT OF 40 MG/DL ON THEIR BLOOD GLUCOSE METER, THEY TREATED HIM WITH IV GLUCOSE. 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 1020207187

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK