BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BGSTAR BGMS

    MDR report key: 3834463 · Received May 2, 2014

    Report

    Report Number
    3004637226-2014-00021
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 12, 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 DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER. NO TEST STRIP LOT INFORMATION WAS PROVIDED. METER DHR SHOWED IT LEFT THE FACTORY OPERATIONAL. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THE EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE PATIENT NOTES HE HAD BEEN GETTING HIGH READINGS AND INCONSISTENCY BETWEEN READINGS WITH THE BGSTAR METER. ON (B)(6) 2014 AT 4:30 AM, HE RECEIVED A BLOOD-GLUCOSE RESULT OF OVER 20 MMOL/L AND DOSED 105 U OF NOVOMIX. THE PATIENT STATES HE NORMALLY TAKES 90 U TWICE DAILY. AT 9:00 AM THE SAME DAY, A PHARMACIST COMPARED THE BGSTAR TO ANOTHER METER AND FOUND A 5 MMOL/L DIFFERENCE. AT 9:30 AM, THE PATIENT FELT LIGHT-HEADED, SWEATY AND EXPERIENCED STOMACH CRAMPS. THE BGSTAR DISPLAYED "LOW." THE PATIENT ATE FOODS UNTIL HIS LEVELS NORMALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264505 BGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC 8000-07434

    Patients

    Seq Age Sex Outcome Treatment
    1 Other