BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 24892399 · Received April 16, 2026

    Report

    Report Number
    2032227-2026-160871
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    December 28, 2025
    Report Date
    April 15, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THIS IS 2 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. 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 REPORTED A SIMPLERA SYNC SENSOR WAS CONNECTED TO A MINIMED 780G INSULIN PUMP WITH SMARTGUARD ENABLED. THE CUSTOMER STATED THAT THE SENSOR DISPLAYED FALSELY ELEVATED GLUCOSE READINGS BETWEEN 325 AND 350 MG/DL, WHICH LED THE PUMP TO DELIVER EXCESSIVE INSULIN. WITHIN APPROXIMATELY 30¿45 MINUTES, THE CUSTOMER¿S GLUCOSE LEVEL DROPPED RAPIDLY. BY APPROXIMATELY 5:00 AM, THE CUSTOMER EXPERIENCED SEVERE HYPOGLYCEMIA. DUE TO LACK OF TEST STRIPS RELATED TO INSURANCE ISSUES, THE CUSTOMER WAS INITIALLY UNABLE TO CONFIRM GLUCOSE LEVELS. A NEIGHBOR LATER PROVIDED TEST STRIPS, AND A FINGERSTICK MEASUREMENT SHOWED A BLOOD GLUCOSE VALUE OF 42 MG/DL. THE CUSTOMER REPORTED THE DIFFERENCES IN THE SENSOR GLUCOSE AND BLOOD GLUCOSE EVENT. THE SENSOR GLUCOSE WAS 0 MG/DL, AND THE BLOOD GLUCOSE VALUE WAS 42 MG/DL. THE CUSTOMER TREATED THE HYPOGLYCEMIA WITH MULTIPLE FAST-ACTING CARBOHYDRATES. THE CUSTOMER REPORTED THAT IT TOOK APPROXIMATELY SEVEN HOURS FOR GLUCOSE LEVELS TO STABILIZE ABOVE 100 MG/DL. THE CUSTOMER STATED THAT THE EVENT WAS CAUSED BY INACCURATE CONTINUOUS GLUCOSE MONITORING READINGS, WHICH RESULTED IN UNSAFE INSULIN DELIVERY. THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND WAS TREATED WITH GLUCOSE/CARB INTAKE, AND SELF TREATED. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE EVENT INVOLVED PRODUCT(S) MMT-242A, MMT-5120A, MMT-1884, AND MMT-332A. TROUBLESHOOTING WAS NOT PERFORMED FOR THE HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED FOR THE LOW BLOOD GLUCOSE. THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS AT THE TIME OF THE EVENT, AND IT WAS UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF THE LOW BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED FOR THE SENSOR GLUCOSE VS BLOOD GLUCOSE, AND THE INSULIN DELIVERY WAS NOT SUSPENDED DUE TO THE SENSOR GLUCOSE VS BLOOD GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-242A,MMT-5120A,MMT-1884, AND MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964498 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 48 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET