BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BGSTAR BGMS

    MDR report key: 3834461 · Received May 2, 2014

    Report

    Report Number
    3004637226-2014-00020
    Event Type
    Injury
    Date Received
    May 2, 2014
    Report Date
    May 1, 2014
    Manufacturer
    AGAMATRIX, INC
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE TEST STRIP LOT (KY14WK73C) DHR HAS BEEN REFERENCED AND THE LOT CLEARED QC TESTING. 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. INSULIN MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    PATIENT DESCRIBES FASTING VALUES ON MORNING AS FOLLOWS: 134 MG/DL, 30 MINUTES LATER 162 MG/DL, 15 MINUTES LATER 97 MG/DL. ANOTHER INSTANCE, THE PATIENT MEASURED BEFORE LUNCH AND THE BGSTAR METER SHOWED 201 MG/DL. THE PATIENT MODIFIED HIS DOSE OF NOVOMIX BY 2 UNITS WITHOUT CONTACTING HIS PHYSICIAN. THE PATIENT THEN CLAIMS HE DEVELOPED HYPOGLYCEMIA 45 MINUTES LATER. AFTER CONTACTING HIS PHYSICIAN, HE TOOK HONEY AND RECOVERED. NORMAL INSULIN DOSAGES IS AS FOLLOWS: MORNING: 8 U NOVORAPID. LUNCH: 10 U NOVORAPID. DINNER: 18 U NOVORAPID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265278 BGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC 8000-05266 KY14WK73C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other