BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 5048928 · Received September 2, 2015

    Report

    Report Number
    3004637226-2015-00032
    Event Type
    Injury
    Date Received
    September 2, 2015
    Report Date
    September 30, 2015
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE METER DHR WAS REFERENCED. THIS SHOWS THE METER LEFT THE FACTORY OPERATIONAL. TEST STRIP LOT INFORMATION WAS NOT PROVIDED. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THERE IS NO EVIDENCE FROM PREVIOUS FIELD RETURNS THE EVENT WAS CAUSED BY A METER MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE HIGH VALUES CANNOT BE DETERMINED. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, OTHER MEDICATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED TO THE DISCREPANT VALUES. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. INSULIN MAY HAVE CONTRIBUTED TO THE HYPOGLYCEMIC EVENT. NO CORRECTIVE ACTION WILL BE INITIATED BECAUSE SYSTEM FAILURE COULD NOT BE CONFIRMED. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED AND HAS BEEN RETURNED TO THE MANUFACTURER. CONFIRMATION TESTING FOUND THE METER TO BE OPERATING WITHIN SPECIFICATION. TEST STRIP LOT INFORMATION WAS NOT PROVIDED. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THERE IS NO EVIDENCE FROM PREVIOUS FIELD RETURNS THE EVENT WAS CAUSED BY A METER MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE HIGH VALUES CANNOT BE DETERMINED. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, OTHER MEDICATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED TO THE DISCREPANT VALUES. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. INSULIN MAY HAVE CONTRIBUTED TO THE HYPOGLYCEMIC EVENT. NO CORRECTIVE ACTION WILL BE INITIATED BECAUSE THE SYSTEM IS OPERATING WITHIN SPECIFICATION. THIS EVENT WILL CONTINUE TO BE TRENDED. FOLLOW-UP SUBMITTED TO INDICATE RETURNED METER, INVESTIGATION RESULTS AND TO CORRECT METER MANUFACTURE DATE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE IBGSTAR METER IS MEASURING HER BLOOD GLUCOSE HIGHER THAN ANOTHER [UNNAMED] METER. CONTROL SOLUTION TESTING PERFORMED ON THE IBGSTAR WERE REPORTED OUT OF RANGE, TOO HIGH : 169 MG/DL AND 168 MG/DL FOR A RANGE OF 108 - 164 MG/DL. DUE TO THE HIGH BLOOD TEST RESULTS, THE PATIENT ADJUSTED HER BLOOD SUGAR WITH 13 UNITS OF INSULIN AND SHE EXPERIENCED HYPOGLYCEMIA. ACTIONS PERFORMED TO TREAT THE HYPOGLYCEMIA WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580611 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 Other