BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR BGMS

    MDR report key: 3925449 · Received June 18, 2014

    Report

    Report Number
    3004637226-2014-00024
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 17, 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 MANUFACTURER. THE METER DHR HAS BEEN REVIEWED AND WAS RELEASED FROM THE FACTORY WITHIN SPECIFICATION. THE OWNER'S GUIDE HAS BEEN CAREFULLY REVIEWED. THERE IS NO INDICATION ON THE EVENT OCCURRED DUE TO POOR LABELING. IBGSTAR FIELD RETURNS REGARDING SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THERE IS NO EVIDENCE THE EVENT OCCURRED DUE TO A COMPONENT FAILURE. INSULIN MAY HAVE CONTRIBUTED TO THE EVENT. THE PT STATES INSULIN WAS DOSED BASED ON THE METER'S BLOOD-GLUCOSE READING. TAKING THE FREQUENCY OF HYPOGLYCEMIC EVENTS (ONCE PER WEEK) INTO ACCOUNT, IT IS POSSIBLE THE PT'S DOSAGE SCALE MAY BE INCORRECT. THE METER'S INVOLVEMENT IN THE INCIDENT IS UNK AS THE PT WAS UNDER THE CARE OF HEALTHCARE PROFESSIONALS. IT IS UNK WHETHER OR HOW THE FACILITY'S PERSONNEL MANAGED THE PT'S DIABETES WHILE UNDER THEIR CARE. THIS EVENT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE PT WAS AT THE HOSPITAL AND UNDER THE CARE OF HEALTH CARE PROFESSIONALS AT THE TIME OF THE EVENT. THE PT WAS THERE FOR FUNCTIONAL REHABILITATION AFTER KNEE SURGERY, IN AN UNRELATED INCIDENT. IN THE NIGHT BETWEEN (B)(6) 2014, THE PT SCREAMED DURING HER SLEEP AND WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. SHE DOES NOT REMEMBER ANYTHING ABOUT THIS EPISODE. SHE KNOWS THAT THE PHYSICIAN ON DUTY WAS CALLED AND THAT SHE HAD INFUSIONS. ANY BLOOD-GLUCOSE MEASUREMENTS, THAT MAY HAVE BEEN TAKEN AT THE TIME OF THE INCIDENT WERE NOT REPORTED. THE PT DOES NOT KNOW HOW LONG THE EPISODE LASTED. NO UNUSUAL STRESS, PHYSICAL ACTIVITY, DIET OR CHANGES IN TREATMENT WERE REPORTED. THE REPORTED DIFFERENCE OF VALUES (408 VERSUS 208) WAS NOT IDENTIFIED AT THE TIME OF THE EPISODE BUT SOMETIMES DURING HER STAY AT HOSPITAL. THE PT OFTEN COMPARED HER TWO YEARS OLD IBGSTAR WITH THE HOSPITAL'S ONE TOUCH VITA AND NOTICED SMALL DIFFERENCES BETWEEN READINGS WHEN VALUES WERE LOW, AND LARGE DIFFERENCES WHEN THEY WERE HIGH. THE PT IS CONVINCED THE HYPOGLYCEMIC EPISODE WAS DUE TO TOO HIGH VALUES GIVEN BY THE METER AND RESULTED IN TOO HIGH DOSES OF INSULIN (NORMAL TREATMENT: LEVEMIR 9 IU IN MORNING, 10 IU IN EVENING AND NOVORAPID AS NEEDED ACCORDING TO BLOOD-GLUCOSE) OR ABSCENCE OF EARLY CORRECTIVE MEASURES. ACCORDING TO HER OWN EVAL, SHE EXPERIENCES SEVERE EPISODES OF HYPOGLYCEMIA EVERY 6 MONTHS AND HAS TO TAKE CORRECTIVE MEASURES FOR HYPOGLYCEMIA ABOUT ONCE A WEEK. THE PT REPORTS NOT TO HAVE PRODROMIC SYMPTOMS OF HYPOGLYCEMIC EPISODES, WHICH SHE STATES, EXPLAINS THEIR SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356784 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening