BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 3949661 · Received June 19, 2014

    Report

    Report Number
    3004637226-2014-00025
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 19, 2014
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. THE METER DHR HAS BEEN REVIEWED AND IT WAS RELEASED FROM THE FACTORY WITHIN SPECIFICATION. NO TEST STRIP LOT INFO WAS GIVEN. THE OWNER'S GUIDE HAS BEEN CAREFULLY REVIEWED. THERE IS NO INDICATION THE EVENT OCCURRED DUE TO POOR LABELING. IBGSTAR FIELD RETURNS REGARDING SIMILAR COMPLAINTS HAVE BEEN REVIEWED AND THERE IS NO EVIDENCE THE EVENT OCCURRED DUE TO A COMPONENT FAILURE. THERE ARE A NUMBER OF FACTORS THAT COULD HAVE CONTRIBUTED TO THE EVENT: THE PT WAS FATIGUED DUE TO A STRESSFUL WEEK PRIOR TO EVENT; THE PT ADJUSTED HIS DIET AND CONSUMED ALCOHOL THE NIGHT BEFORE THE EVENT; ADDITIONAL INSULIN WAS DOSED TWO HOURS BEFORE THE EVENT; THE METER ACCURATELY DETECTED THE PT'S HYPOGLYCEMIC STATE TEN MINUTES BEFORE THE EVENT. THE PT'S ATTEMPT TO CORRECT WAS TOO LATE DUE TO THE ABSENCE OF PRODROMIC SYMPTOMS. IN EVERY INSTANCE THE IBGSTAR WAS COMPARED TO ANOTHER BLOOD-GLUCOSE READING, THE TWO VALUES WERE WITHIN 15% OF THEIR AVERAGE. THIS IS AN ACCEPTABLE VARIATION. THE COMPARISON OF THE IBGSTAR METER WITH A VENOUS SAMPLE IS OUTSIDE THE METER'S INTENDED USE. THE DIFFERENCE IN VALUES DUE TO THAT TESTING CANNOT BE CONFIRMED. BASED ON THE NUMBER OF TRIGGERING EVENTS PRIOR THE EVENT, THE METER'S ABILITY TO DETECT THE HYPOGLYCEMIC STATE, AND THE METER OPERATING NOMINALLY DURING EVERY COMPARISON TEST, THE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT WILL BE TRENDED.

    Description of Event or Problem · 1

    ORIGINAL COMPLAINT RECEIVED (B)(6) 2014. IT DESCRIBED THE COMPARISON BETWEEN METER AND LAB, AND MENTIONED A HYPOGLYCEMIC EVENT. THE BELOW INFO WAS RECEIVED (B)(6) 2014 FROM A FOLLOW-UP. FOR TWO YEARS THE PT HAS HAD AN EXTERNAL PUMP WITH CONTINUOUS NOVORAPID AND 4 TO 5 BOLUS PER DAY ACCORDING TO IBGSTAR BLOOD-GLUCOSE READINGS. HE HAD PREVIOUSLY COMPARED BLOOD-GLUCOSE READINGS OF THE IBGSTAR METER TO THAT OF THE OPTIUM XCEED METER. THE IBGSTAR READ 0.20 G/L HIGHER. THE PT REPORTS THE WEEK PRIOR TO THE EVENT WAS DIFFICULT DUE TO EXAMS AND THAT HE WAS TIRED FROM THEM. HE ALSO REPORTS HE WAS AT A WEDDING THE NIGHT PRIOR TO THE EVENT AND THOUGH ATE DIFFERENTLY THAN NORMAL AND CONSUME ALCOHOL, BOTH WERE MANAGED. ON (B)(6) 2014, HE DOSED HIS NOVORAPID BOLUS AT 09:00 AM AFTER GETTING HIS BLOOD-GLUCOSE MEASUREMENT FROM HIS IBGSTAR. THE METER READING WAS NOT PROVIDED. AT 11:00 AM, THE IBGSTAR READ 0.30 G/L. DESPITE SUGAR INTAKE, FIVE TO TEN MINUTES LATER HE EXPERIENCED A SEIZURE AND WAS TAKEN TO THE EMERGENCY ROOM. THE PT KNOWS HE HAD INFUSION AND A BRAIN CT SCAN (NO ISSUES FOUND) WHILE AT THE HOSP. HE WAS TOLD HIS BLOOD CREATININE WAS TEMPORARILY HIGH AND IMPROVED WITH HYDRATION. THE PT REPORTS HE HAS NEVER HAD A SEIZURE BEFORE. HE REPORTS HIS ONLY POSSIBLE PRODROMIC SYMPTOM WAS SHAKING OF THE LEG. THE PT STAYED EIGHT HOURS IN THE HOSP BEFORE DISCHARGE. EITHER (B)(6) 2014, THE PT COMPARED HIS BLOOD GLUCOSE RESULT TO THAT OF A VENOUS BLOOD TEST. THE IBGSTAR READ 0.92 G/L AND THE VENOUS BLOOD SAMPLE, 0.69 G/L. THE PT THEN COMPARED HIS NEW METER TO HIS OLD METER ONCE HE RECEIVED HIS REPLACEMENT IBGSTAR. THE OLD METER READ 1.30 G/L WHILE THE NEW METER, 1.10 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359482 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| O