BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 6090802 · Received November 9, 2016

    Report

    Report Number
    3004637226-2016-00014
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    December 12, 2016
    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 RETURNED TO THE MANUFACTURER. THE METER IS 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 INACCURATE VALUES CANNOT BE DETERMINED. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, OTHER MEDICATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED THOUGH INSULIN OR DIET COULD HAVE CONTRIBUTED. NO CORRECTIVE ACTION WILL BE INITIATED BECAUSE THE METER IS OPERATING WITHIN SPECIFICATION. THIS EVENT WILL CONTINUE TO BE TRENDED. UPDATE/CORRECTIONS: UPDATED MODEL #/LOT # TO CORRECT SERIAL NUMBER. THE INCORRECT SERIAL NUMBER WAS REPORTED BY THE CALLER. UPDATED DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE TO INCLUDE METER RETURN AND CONFIRMATION INVESTIGATION RESULTS. THE CONFIRMATION INVESTIGATION RESULTS DO NOT CHANGE THE ROOT CAUSE ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE METER DHR WAS REFERENCED. IT SHOWS THE METER LEFT THE FACTORY 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 INACCURATE VALUES CANNOT BE DETERMINED. FACTORS SUCH AS HEMATOCRIT, TEMPERATURE, HUMIDITY, ELEVATION, OTHER MEDICATION, AND TESTING PROCEDURE MAY HAVE CONTRIBUTED. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED THOUGH INSULIN OR DIET COULD HAVE CONTRIBUTED. NO CORRECTIVE ACTION WILL BE INITIATED BECAUSE SYSTEM FAILURE COULD NOT BE CONFIRMED. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE PATIENT CALLED THE INSULIN CALL CENTER REPORTING A FAILURE OF THE IBGSTAR. THE PATIENT REPORTED THAT SHE EXPERIENCED TWO HYPOGLYCAEMIC EPISODES, WHICH SHE DID NOT ATTRIBUTE TO LANTUS (INSULIN GLARGINE) SOLOSTAR TREATMENT, BUT DIRECTLY TO A FAILURE OF THE BLOOD GLUCOSE METER. ON (B)(6) SHE EXPERIENCED A POST-PRANDIAL HYPOGLYCAEMIA AT LUNCH TIME OF 68 MG/DL, WHICH OCCURRED WITH DIZZINESS AND SWEATING. ITS RESOLUTION WAS UNKNOWN. ON (B)(6) THE PATIENT EXPERIENCED A PRE-PRANDIAL HYPOGLYCAEMIC EVENT AT BREAKFAST TIME AND NOTICED DIZZINESS AND SWEATING. SHE TOOK A SWEET AS TREATMENT. AFTER SOME MINUTES THE PATIENT REPEATED A MEASUREMENT SHOWING A VALUE OF 53 MG/DL. SHE DRANK A JUICE AND SOME MINUTES LATER SHE REPEATED AGAIN AND THE READING SHOWED A VALUE OF 77 MG/DL. THE BLOOD GLUCOSE READINGS AND THE AMOUNT OF INSULIN ADMINISTERED BEFORE THE EVENTS ARE NOT REPORTED NOR IS THE TIME ELAPSED BETWEEN THE INSULIN INJECTION AND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739738 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05709

    Patients

    Seq Age Sex Outcome Treatment
    1 Other