BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 22294687 · Received June 20, 2025

    Report

    Report Number
    2032227-2025-194067
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 20, 2025
    Report Date
    August 5, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    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. 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

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. 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. THE CUSTOMER ALSO REPORTED THE LOSS OF COMMUNICATION BETWEEN THE INSULIN PUMP AND TRANSMITTER AND THE METER. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 469 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED FOR LOSS OF COMMUNICATION, AND THE CUSTOMER RECEIVED A DEVICE NOT FOUND ALERT. TROUBLESHOOTING WAS NOT PERFORMED FOR HIGH BLOOD GLUCOSE. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHETHER THE CUSTOMER USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1880.

    Description of Event or Problem · 0

    UPDATED SUMMARY: THIS A DUPLICATE COMPLAINT. THE REGULATORY REPORT FOR SAME EVENT WAS ALREADY SUBMITTED WITH (2032227-2025-192778). HENCE THE EVENT REPORTED UNDER REGULATORY NUMBER 2032227-2025-194067 IS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747888 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 HG5VKX4ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other FRN-UNK_RESERVOIR-RSVR, UNOMED INF SET.