BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 3213955 · Received July 3, 2013

    Report

    Report Number
    3004637226-2013-00011
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF BOTH THE OWNER'S GUIDE AND SIMILAR COMPLAINTS WAS PERFORMED. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED.

    Description of Event or Problem · 1

    USER MEASURED READING OF 22.9 MMOL/L WITH IBGSTAR. USER DID NOT FEEL SYMPTOMATIC. USER INJECTED 8 UNITS OF NOVORAPID, BASED ON READING. TWO HOURS LATER, IBGSTAR READING WAS 22 MMOL/L. USER INJECTED MORE NOVORAPID WITHOUT FOOD. USER MEASURED BLOOD SUGAR AGAIN AN HOUR LATER IBGSTAR READING WAS 26 MMOLS. USER WAS ASYMPTOMATIC WITH THESE 'HIGH' RESULTS. USER WENT TO BED AND DURING THE NIGHT HAD SYMPTOMS OF A HYPOGLYCEMIC ATTACK (TONGUE NUMBNESS, SHAKING AND SWEATING). MEMBER TREATED HYPOGLYCEMIA SYMPTOMS WITHOUT TAKING A READINGS. USER STATED HE FELT LIKE HE WAS READING AROUND 2 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306010 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-08131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other