BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BGSTAR BGMS

    MDR report key: 4172053 · Received October 10, 2014

    Report

    Report Number
    3004637226-2014-00031
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    October 9, 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 BEEN RETURNED TO THE DISTRIBUTOR. CONFIRMATION TESTING PERFORMED BY THE DISTRIBUTOR SHOWS THE METER IS OPERATING WITHIN SPECIFICATION. NO TEST STRIP LOT INFORMATION WAS PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. THERE WAS NO INDICATION THE PATIENT DOSED BASED ON METER READINGS. A NORMAL BLOOD-GLUCOSE VALUE FOR THE PATIENT WAS NOT GIVEN. IT IS POSSIBLE THE PATIENT COULD EXPERIENCE HYPOGLYCEMIC SYMPTOMS WITH BLOOD GLUCOSE VALUES AROUND 81 MG/DL. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. NO CORRECTIVE ACTION WILL BE PERFORMED BECAUSE THE METER WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE INITIAL COMPLAINT, RECEIVED (B)(6) 2014, REPORTED THAT THE BGSTAR METER WAS MEASURING BLOOD-GLUCOSE VALUES TOO HIGH. THE PATIENT BECAME HYPOGLYCEMIC AND WAS ADMITTED TO THE HOSPITAL. A LETTER DATED (B)(6) 2014 AND RECEIVED (B)(6) 2014 STATES THE BGSTAR MEASURED 81 MD/DL AND ANOTHER DEVICE MEASURED 42 MG/DL. THE PATIENT WAS THEN DESCRIBED AS BECOMING COMATOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643117 BGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R