BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NGP

    MDR report key: 23966671 · Received January 5, 2026

    Report

    Report Number
    2032227-2025-326894
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 6, 2025
    Report Date
    January 5, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND RECEIVED CHANGE SENSOR AND SENSOR UPDATING ALARMS. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 400 MG/DL, AND THE HYPERGLYCEMIC EVENT TREATMENT WAS NOT MENTIONED. THE EVENT INVOLVED PRODUCT(S) MMT-441AG, MMT-5120A, UNKNOWN NGP, MMT-342. TROUBLESHOOTING WAS PERFORMED FOR HYPERGLYCEMIA. CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. CUSTOMER WAS USING THE AUTO MODE FEATURE AT THE TIME OF THE EVENT. CUSTOMER ALLEGES PUMP IS UNDER DELIVERING BECAUSE THE PUMP IS GIVING MANUAL BOLUSES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-441AG, MMT-5120A, UNKNOWN NGP, MMT-342 PRODUCTS WERE NOT EXPECTED TO RETURN. FRN-MMT-342-RSVR, UNOMED INF SET, SFI-MMT-5120A-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28566 UNKNOWN NGP AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other RESERVOIR (FRN) / INFUSION SET (FPA).