BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24302328 · Received February 10, 2026

    Report

    Report Number
    2032227-2026-123794
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 19, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    0000763000960032
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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.

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS OR REWIND ANOMALY NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. DURING DOWNLOAD HISTORY REVIEW, INSULIN FLOW BLOCKED ALARM OCCURRED ON 01/19/2026 22:13:58.000, 01/19/2026 22:14:58.000 AND 01/19/2026 22:42:10.000 DURING PRIMING IN PUMP DOWNLOADED HISTORY. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. PER OBSERVATION THAT THE KNIT LINE NEAR THE BELT CLIP PLATE IS NORMAL. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE (MINOR). NO CRACKS ON THE CASE DURING THE VISUAL INSPECTION. UNEXPECTED INSULIN FLOW BLOCKED ALARM AND REWIND ANOMALY WERE NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED WITH MINOR SCRATCHED CASE. 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 AN INSULIN FLOW BLOCKED ALARM AND ALSO REPORTED PUMP IS BROKEN BECAUSE IT IS NOT ALLOWING TO DO A REWIND. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-1884, MMT-243A. TROUBLESHOOTING WAS PARTIALLY PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS REQUIRED FOR MMT-332A, MMT-1884, MMT-243A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17510 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 NG4208080H 0000763000960032

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male