BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BGSTAR BGMS

    MDR report key: 3925420 · Received June 18, 2014

    Report

    Report Number
    3004637226-2014-00023
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    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. NO TEST STRIP LOT INFO WAS PROVIDED. NO METER SERIAL NUMBER WAS PROVIDED. BASED ON THE LIMITED INFO PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. INSULIN MAY HAVE CONTRIBUTED TO THE HYPOGLYCEMIC EVENT. THERE WAS NO INDICATION IN THE REPORT THAT THE PT DOSED BASED ON METER READINGS. A NORMAL BLOOD-GLUCOSE VALUE FOR THE PT WAS NOT GIVEN. IT IS POSSIBLE THAT THE PT COULD EXPERIENCE HYPOGLYCEMIC SYMPTOMS WHILE THE METER RESULTED IN VALUES OF 84, 86 AND 115 MG/DL. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THE OWNER'S GUIDE INSTRUCTS USERS TO CONTACT THEIR HEALTH PROFESSIONALS IF READINGS DO NOT SUPPORT THEIR SYMPTOMS. THERE IS NO INDICATION THIS WAS DONE. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    AT THE TIME OF THE DESCRIBED INCIDENT, THE PT WAS INVOLVED IN A CLINICAL STUDY (B)(6). ON AN UNSPECIFIED DATE, THE PT COMMENCED THERAPY WITH INSULIN GLARGINE (ROUTE, FORM, DOSE, LOT/BATCH NUMBER AND EXPIRY DATE NOT REPORTED). ON (B)(6) 2013, SHE STARTED USING THE BGSTAR METER. ON (B)(6) 2014, THE PT HAD A FALL WITH MILD TRAUMATIC HEAD INJURY DUE TO SYMPTOMS OF HYPOGLYCEMIC (NAUSEA, BLURRED VISION, FEELING FAINT). SHE HAD MEASURED HER BLOOD-GLUCOSE AT 03:11 AM WITH THE BGSTAR: 86 MG/DL. SHE THEN TRIED TO EAT BUT SHE COULDN'T BECAUSE OF THE HYPOGLYCEMIC SYMPTOMS. SHE MEASURED AGAIN WITH THE BGSTAR AND HER BLOOD-GLUCOSE WAS 82 MG/DL. IT IS AT THIS POINT SHE FELL AND HAD TO RECEIVE HONEY AND SUGAR, ADMINISTERED BY HER HUSBAND, TO RECOVER. AFTER RECOVERY, SHE CONDUCTED A CONTROL SOLUTION TEST (RESULT NOT PROVIDED) AND MEASURED HER BLOOD-GLUCOSE TO BE 115 MG/DL. AT 03:48 AM SHE RECOVERED FROM HER HYPOGLYCEMIC SYMPTOMS, HER BLOOD-GLUCOSE MEASURED 162 MG/DL BUT SHE HAD A HEADACHE. THE HEADACHE REMAINED UNTIL 10:00 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356780 BGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-10191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other