BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2548576 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00019
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    November 10, 2011
    Report Date
    April 16, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METER REQUESTED FROM CUSTOMER. REPORT WILL BE UPDATED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN (B)(6) 2011, BASAL BOLUS WAS STOPPED AND PT WAS PRESCRIBED INSULIN PUMP WITH ACTRAPID AND SHE CHOSE IBGSTAR AS GLUCOSE METER TO GET ALL HER BLOOD GLUCOSE VALUES RECORDED. PT REPORTED THAT IT TOOK HER AROUND 15 DAYS TO ADJUST INSULIN DOSES FROM INSULIN PUMP SINCE BLOOD GLUCOSE VALUES MEASURED WITH IBGSTAR SEEMED TO BE HIGHER AND SHE CONSEQUENTLY INCREASED INSULIN DOSE AND SHE DEVELOPED HYPOGLYCEMIA. PT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other