BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120C INSTINCT 780 5PK OUS 1

    MDR report key: 25038993 · Received April 30, 2026

    Report

    Report Number
    2032227-2026-168044
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    SENSOR CARELINK ADDITIONAL INVESTIGATION WAS PERFORMED FOR THE SENSOR GLUCOSE VS. BLOOD GLUCOSE ISSUE. UNABLE TO ESTABLISH ROOT CAUSE OF COMPLAINT FROM ANALYSIS. UPON REVIEW, THE SENSOR PERFORMED WITHIN SPECIFICATIONS AND THE CAUSE COULD NOT BE DETERMINED. 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 HYPOGLYCEMIA DUE TO A DISCREPANCY IN READING BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES. THE CUSTOMER REPORTED HYPOGLYCEMIA OF 54 MG/DL WAS TREATED WITH CARB INTAKE. THE EVENT INVOLVED PRODUCT(S) MMT-5120C1. TROUBLESHOOTING WAS PERFORMED AND THE DISCREPANCY BETWEEN THE SENSOR GLUCOSE VALUE OF 174 MG/DL AND BLOOD GLUCOSE VALUE OF 54 MG/DL WAS NOT WITHIN THE TARGET RANGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN REQUIRED FOR MMT-5120C1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353178 SENSOR MMT-5120C INSTINCT 780 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120C1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown