BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 4058852 · Received August 22, 2014

    Report

    Report Number
    3004637226-2014-00027
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 19, 2014
    Manufacturer
    AGAMATRIX INC
    Product Code
    CGA
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR AND IS PENDING INVESTIGATION. THE METER DHR WAS REFERENCED. THE METER WAS RELEASED FROM THE FACTORY WITHIN SPECIFICATION. NO TEST STRIP LOT INFO WAS PROVIDED. THE OWNER'S MANUAL WAS CAREFULLY REVIEWED. THERE IS NO INDICATION THE EVENT OCCURRED DUE TO POOR LABELING. AN ANALYSIS OF FIELD RETURNS REGARDING IBGSTAR METERS AND SIMILAR COMPLAINTS SHOWS NO ACCURACY ISSUES ATTRIBUTED TO METER MALFUNCTION HAVE BEEN CONFIRMED. BASED ON THE LIMITED INFO PROVIDED, THE ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED. THIS COMPLAINT WILL BE TRENDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A (B)(6) YEAR OLD MALE CONSUMER REPORTED THAT HE EXPERIENCED HYPOGLYCEMIA, BUT THE METER WAS GIVING HIM FALSE HIGH READINGS. HE STATED THIS MORNING THAT THE IBGSTAR METER MEASURED HIS BLOOD GLUCOSE TO BE 5.8 MMOL/L. HE FELT DIZZY AND WAS CONVINCED HE WAS EXPERIENCING HYPOGLYCEMIA. HE DECIDED TO TEST WITH HIS ONE TOUCH METER. THAT MEASURED HIS BLOOD-GLUCOSE TO BE 2.8 MMOL/L. HE IS TAKING LANTUS (INSULIN GLARGINE) 40 UNITS DAILY AND NOVORAPID (INSULIN ASPART) ON A SLIDING SCALE. HE TRIED A CONTROL SOLUTION SET, WHICH FELL WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508597 IBGSTAR BGMS BLOOD GLUCOSE METER CGA AGAMATRIX INC 8000-06958

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other