BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23563790 · Received November 15, 2025

    Report

    Report Number
    2032227-2025-300373
    Event Type
    Injury
    Date Received
    November 15, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT WITHIN SPECIFICATION AT .08660 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO PUMP ERROR 53 ALARM (PUMP ALARM DURING CARELINK UPLOAD). ON THE EVENT DATE OF 29-SEP-2025, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOTED. ON THE EVENT DATE OF 29-SEP-2025 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 233000 (23.3 U) AND DAILYTOTALOFBOLUSINSULINDELIVERED = 70750 (7.075 U) WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 303750 (30.375 U). ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 29-SEP-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: 09/28/2025 14:03:22.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON 29-SEP-2025 DURING BOLUS DELIVERY. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. PUMP ERROR 53 ALARM (LINENUMBER 8192 FILENUMBER 8792 & LINENUMBER 1474 FILENUMBER 26) DURING CARELINK UPLOAD WAS FOUND ON: 11/17/2025 14:06:53.000, 11/17/2025 14:16:00.000 . 11/17/2025 14:20:44.000, 11/17/2025 14:23:47.000 . 11/17/2025 14:33:00.000 . 11/20/2025 06:05:18.000, 11/20/2025 06:47:48.000 . 11/20/2025 06:48:53.000, 11/20/2025 06:51:25.000 . 11/20/2025 06:59:31.000 . AS PER R&D ENGINEER, (B)(6): PUMP GENERATED SEVERAL PUMP ERRORS 53 (FILENUM/LINENUM=8792/8192) DUE TO USAGE EXCEPTION ON MAIN MCU -SUSPECTING THE HW ISSUE (BUM). PUMP ERROR 53 (FILENUM/LINENUM=26/1474) WAS NOT A SEPARATE ALARM BUT JUST POINT WHEN THE PE53 WAS ESCALATED TO A SIREN. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (24.48 MV). PUMP ERROR 53 ALARM (LINENUMBER 8192 FILENUMBER 8792 & LINENUMBER 1474 FILENUMBER 26) DURING CARELINK UPLOAD WAS CONFIRMED, SUSPECTED ON HW. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITH A BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO PUMP ERROR 53 ALARM (PUMP ALARM DURING CARELINK UPLOAD). PUMP ERROR 53 ALARM (LINENUMBER 8192 FILENUMBER 8792 & LINENUMBER 1474 FILENUMBER 26) DURING CARELINK UPLOAD WAS CONFIRMED, SUSPECTED ON HW. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 AND THE INSULIN PUMP IN USE LEADING UP TO THE HOSPITALIZATION. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 640 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS WAS TREATED WITH THE MANUAL INJECTION/INSULIN PEN, AN IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION) AND HOSPITALIZATION. ALSO, THE CUSTOMER REPORTED THE MALAISE, FATIGUE, AND HEADACHE WAS TREATED WITH HOSPITALIZATION. THE EVENT INVOLVED PRODUCTS MMT-397A, MMT-332A, AND MMT-1880. 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 MMT-397A AND MMT-332A. MMT-1880 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563482 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 HG595MYZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention| H FRN-MMT-332A-RSVR, UNOMED INF SET