BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24468234 · Received February 27, 2026

    Report

    Report Number
    2032227-2026-136283
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, REWIND, SEATING, BASIC OCCLUSION TEST, FORCE SENSOR TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF-TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO PUMP ERROR 63 ALARMS OR UNEXPECTED FAILED BATTERY TEST DURING TESTING. DURING DOWNLOAD HISTORY REVIEW, FAILED BATTERY TEST OCCURRED ON (B)(6) 2026 22:12:13 AND (B)(6) 2026 22:13:31 AND PUMP ERROR 63 (LINENUMBER: 5932 FILENUMBER: 632 VARIABLES: 21) WAS PRESENT IN THE HISTORY DOWNLOAD ON (B)(6) 2026 22:12:10.000 DUE TO HARDWARE ERROR WITH THE RF CHIP. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED CASE. PUMP ERROR 63 WAS CONFIRMED DUE TO HARDWARE ERROR. FAILED BATTERY TEST WAS NOT CONFIRMED DURING TESTING. UNABLE TO CONFIRM HIGH BG'S. 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 341 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA WAS TREATED WITH AN INSULIN PUMP. THE EVENT INVOLVED PRODUCT(S) 78893-01, MMT-242A, MMT-332A, MMT-1884. THE CUSTOMER RECEIVED PUMP ERROR 63 (HARDWARE LOW LEVEL FAILURES.). TROUBLESHOOTING WAS PERFORMED. THE SENSOR WAS NOT WORKING SINCE NEW BATTERY WAS INSERTED. THE CUSTOMER RECEIVED BATTERY FAILED ALARM. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR 78893-01, MMT-242A, MMT-332A, MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92666 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG4282380H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1