BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 24841992 · Received April 10, 2026

    Report

    Report Number
    2032227-2026-157509
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 9, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 HYPOGLYCEMIA. THE CUSTOMER ALSO REPORTED A DIFFERENCE BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES. THE CUSTOMER WAS TREATED WITH GLUCAGON SHOTS, HONEY, AND STAYED IN THE EMERGENCY ROOM. THE CUSTOMER ALSO EXPERIENCED THE SYMPTOMS OF PASSING OUT. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-242A, MMT-5120A, MMT-1884. TROUBLESHOOTING WAS NOT PERFORMED FOR SENSOR GLUCOSE AND BLOOD GLUCOSE, AND IT WAS UNKNOWN WHETHER THE INSULIN DELIVERY WAS SUSPENDED OR NOT. THE BLOOD GLUCOSE VALUE WAS 31 MG/DL, AND THE SENSOR GLUCOSE VALUE WAS 120 MG/DL AT THE TIME OF THE EVENT. THE DIFFERENCE BETWEEN BLOOD GLUCOSE AND SENSOR GLUCOSE WAS OUTSIDE THE ACCEPTABLE RANGE. TROUBLESHOOTING WAS NOT PERFORMED FOR HYPOGLYCEMIA. 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 WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-242A. NO PRODUCT RETURN IS REQUIRED FOR MMT-5120A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. FRN-MMT-332A-RSVR, UNOMED INF SET, PQF-MMT-5120A-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899818 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 66 YR Male Required Intervention