BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 25305731 · Received May 27, 2026

    Report

    Report Number
    2032227-2026-179303
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 RECEIVED A CHANGE SENSOR, AND SENSOR UPDATING ALERT. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 400+ MG/DL. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND WAS TREATED WITH AN INSULIN PUMP, AND MANUAL INJECTION/INSULIN PEN. THE CUSTOMER EXPERIENCED BLEEDING. THE EVENT INVOLVED PRODUCT(S) MMT-5120MA, MMT-1884, UNOMEDICAL, AND UNK_RESERVOIR. TROUBLESHOOTING WAS PERFORMED FOR THE CHANGE SENSOR ALERT, AND THE SENSOR SECURELY TAPED TO SKIN AND IS STILL IN PLACE. TROUBLESHOOTING WAS NOT PERFORMED FOR THE HIGH BLOOD GLUCOSE. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS BEFORE THE EVENT AND WHETHER THE AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED FOR THE SITE ISSUES, AND THE CUSTOMER NOT RECEIVED MEDICAL TREATMENT AS A RESULT OF THE SITE ISSUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-5120MA, MMT-1884, UNOMEDICAL, AND UNK_RESERVOIR.FRN-UNK-RSVR, UNOMED SET, SFI-MMT-5120MA- SNSR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535293 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 NG4172072H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1