BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780X 670G MILLIGRAM

    MDR report key: 11379248 · Received February 25, 2021

    Report

    Report Number
    2032227-2021-118396
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    January 28, 2021
    Report Date
    February 25, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. MEDTRONIC, INC.

    Description of Event or Problem · 1

    THE FIRST COMMERCIAL HYBRID CLOSED-LOOP (HCL) SYSTEM BECAME AVAILABLE IN 2016 AFTER CLINICAL TRIALS REVEALED INCREASED TIME IN RANGE (TIR) WITH A REDUCTION IN HYPOGLYCEMIA FOR PARTICIPANTS WITH TYPE 1 DIABETES. HOWEVER, AUTOMATED INSULIN DELIVERY TECHNOLOGY IS CONSTRAINED BY THE PHARMACOKINETICS OF CURRENT SUBCUTANEOUSLY DELIVERED INSULIN ANALOGS. FASTER-ACTING INSULIN ASPART, FIASP (<NAME OMITTED>), OFFERS A MORE RAPID ONSET OF INSULIN ACTION WHEN COMPARED WITH CURRENT RAPID-ACTING INSULIN ANALOGS. THE MINIMED 670G (MEDTRONIC, (B)(4)) HCL SYSTEM AUTOMATICALLY ADJUSTS BASAL RATES THROUGHOUT THE DAY AND NIGHT TO MINIMIZE HYPER- AND HYPOGLYCEMIA. THIS STUDY WAS CONDUCTED TO DETERMINE IF THE USE OF FIASP MADE A CLINICAL DIFFERENCE IN REAL-WORLD PERFORMANCE THAT WAS ALSO DETECTABLE BY THE PARTICIPANTS OR PHYSICIANS. THIS RANDOMIZED CROSSOVER DOUBLE-BLINDED PILOT STUDY COMPARED THE USE OF FIASP VERSUS NOVOLOG IN AN HCL SYSTEM. ADULT PARTICIPANTS (AGE = 18 YEARS) WERE ELIGIBLE IF USING ANY INSULIN ASPART FORMULATION IN A MINIMED 670G PUMP FOR AT LEAST 1 MONTH WITH A TOTAL DAILY DOSE OF AT LEAST 0.3 UNITS/(KGDAY), HEMOGLOBIN A1C (HBA1C) BETWEEN 6% AND 10%, AND CONSUMING AT LEAST 60 G OF CARBOHYDRATES A DAY. PARTICIPANTS WERE EXCLUDED IF THEY HAD A HYPOGLYCEMIC SEIZURE OR SEVERE EPISODE OF DIABETIC KETOACIDOSIS IN THE 6 MONTHS BEFORE SCREENING, ACTIVE PROLIFERATIVE DIABETIC RETINOPATHY, OR PRESENCE OF OTHER SIGNIFICANT MEDICAL CONDITIONS SUCH AS ADRENAL DISORDERS AND RENAL FAILURE. THE FIRST WEEK OF INSULIN USE WAS TO ALLOW ADAPTATION OF THE MINIMED 670G SYSTEM TO THE ASSIGNED BLINDED INSULIN. ALL COMPARISONS BETWEEN THE INSULINS WERE MADE DURING THE SECOND WEEK THAT THEY WERE USED IN THE MINIMED 670G PUMP. A TOTAL OF 43 INDIVIDUALS WERE INVITED TO PARTICIPATE IN THE STUDY THROUGH A LOCAL DIABETES RESEARCH DATABASE OR DURING A CLINIC APPOINTMENT. NINETEEN PARTICIPANTS (10 MALE AND 9 FEMALE) WERE RANDOMIZED AND COMPLETED THE CROSSOVER STUDY. MEAN AGE WAS 40.4 ¿ 17.7 YEARS (RANGE 18¿76) AND MEAN DURATION OF DIABETES WAS 26.6 ¿ 12.3 YEARS (RANGE 9.4¿53.3). THERE WERE NO DIABETIC KETOACIDOSIS, SEVERE HYPOGLYCEMIA, OR OTHER SERIOUS ADVERSE EVENT EPISODES DURING THE TRIAL; NO REPORTED EARLY INFUSION SET FAILURES IN THE GROUP ASSIGNED TO FIASP; AND TWO REPORTED EARLY INFUSION SET FAILURES IN THE GROUP ASSIGNED TO NOVOLOG. OF THE EARLY INFUSION SET FAILURES, ONE WAS DUE TO THE INFUSION SET KINKING AND ANOTHER WAS DUE TO LOCAL IRRITATION/INFLAMMATION AT THE INFUSION SITE. THE SET FAILURE DUE TO INFUSION SET KINKING RESULTED IN AN ADMITTANCE TO THE EMERGENCY ROOM FOR HYPERGLYCEMIA WITH BLOOD SUGARS > 500 AND KETONES OF 2.5 MMOL/L, BUT DID NOT MEET THE CRITERIA FOR DIABETIC KETOACIDOSIS. IN THIS PILOT STUDY, FIASP USE IN THE MINIMED 670G SYSTEM DID NOT DEMONSTRATE A SIGNIFICANT GLYCEMIC BENEFIT OVER NOVOLOG. THE 3.1% DIFFERENCE IN TIR DID NOT QUITE REACH STATISTICAL SIGNIFICANCE (P = 0.051) AND DIFFERENT RESULTS MAY HAVE BEEN SEEN WITH A LARGER CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278036 PUMP MMT-1780X 670G MILLIGRAM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780X

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization