BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 25108469 · Received May 7, 2026

    Report

    Report Number
    2032227-2026-170761
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 A DISCREPANCY BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE VALUE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-5120A. TROUBLESHOOTING WAS PERFORMED, AND IT WAS DETERMINED THAT THE DISCREPANCY BETWEEN THE SENSOR GLUCOSE VALUE OF 80 MG/DL AND THE CORRESPONDING BLOOD GLUCOSE VALUE OF 390 MG/DL EXCEEDED THE ACCEPTABLE RANGE. THE CUSTOMER FURTHER REPORTED THAT INSULIN DELIVERY WAS NOT SUSPENDED DURING THIS PERIOD. THE CUSTOMER WAS INFORMED THAT THE SENSOR MAY NO LONGER BE RESPONDING TO GLUCOSE CHANGES, AND POSSIBLE CAUSES WERE EXPLAINED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS NOT REQUIRED FOR MMT-5120A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203876 SENSOR MMT-5120A SIMPLERA SYNC 5PK US SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male