BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23208596 · Received October 3, 2025

    Report

    Report Number
    2032227-2025-275224
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 3, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0872 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, TORN DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, FADED/STAINED SERIAL NUMBER LABEL, FADED END CAP ADDRESS LABEL, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT THE BATTERY CAP. ON THE EVENT DATE OF 11-SEP-2025 OF THE DAILY TOTAL COLLECTION START TIME, THE DAILY TOTAL OF BASAL INSULIN DELIVERED = 104750 (10.475 U) AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 47000 (4.7 U) WHICH IS EQUAL TO THE DAILY TOTAL OF ALL INSULIN DELIVERED = 151750 (15.175 U). PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 11-SEP-2025, THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED IN THE PUMP HISTORY FILE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.8 MV). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS (HYPERGLYCEMIA)/DKA. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 546 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, AND DIABETIC KETOACIDOSIS WAS TREATED WITH AN IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION) AND HOSPITALIZATION. ALSO, THE CUSTOMER REPORTED THE SYMPTOMS OF CONFUSION, HEADACHE, AND VOMITING WAS TREATED WITH HOSPITALIZATION. THE EVENT INVOLVED PRODUCTS UNOMEDICAL, MMT-1880, AND MMT-332A. TROUBLESHOOTING WAS PARTIALLY PERFORMED, AND IT WAS UNKNOWN WHETHER THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT OR NOT. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USED THE AUTO MODE FEATURE AT THE TIME OF THE EVENT OR NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL AND MMT-332A. PRODUCT RETURN WAS REQUIRED FOR MMT-1880.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312625 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG5W6CYZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Required Intervention| H FRN-MMT-332A-RSVR, UNOMED INF SET.