BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 24565790 · Received March 10, 2026

    Report

    Report Number
    2032227-2026-142252
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 9, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    UDI-DI
    000020763000956381
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    WE RECEIVED THE FOLLOWING: ONE WITH SENSOR AND/OR SERTER IN USED CONDITION, AND PERFORMED A VISUAL INSPECTION OF THE SENSOR, TOOK AWAY THE ADHESIVE PATCH FROM THE SENSOR TO INSPECT FOR DEBRIS, PHYSICAL AND MOISTURE DAMAGE AND NONE WAS FOUND. THEN INSPECTED THE SENSOR FLEX ANY PHYSICAL DAMAGE AND FOUND THE FLEX BENT ALONG THE WORKING ELECTRODE. CHECKED THE TRANSMITTER CASING FOR ANY PHYSICAL/COSMETIC DAMAGE AND NONE WERE FOUND. THEN, PERFORMED A VISUAL INSPECTION ON THE SERTER PRODUCT FOR PHYSICAL/COSMETIC DAMAGE (DENTS OR CRACKS ON THE SERTER SHELL/CAP-TYREK), NONE WERE FOUND. THE UNIT WAS ABLE TO DOWNLOAD TRACES THROUGH (THE BLUE DONGLE DOWNLOAD STATION) (UTILIZING SYNERGY PROD DOWNLOAD TOOL 1.2A). UNIT WAS ABLE TO DOWNLOAD TRACE AND TERMINATION RESULT. FIRST TERM REASON: HIGH IMPEDANCE. FIRST TERM REASON DESCRIPTOR: THE SENSOR WAS TERMINATED DUE TO DETECTED HIGH IMPEDANCE FROM WHICH IT CANNOT RECOVER. THIS IS A SAFEGUARD DESIGNED WITHIN ALGORITHM FOR PATIENT SAFETY. IN CONCLUSION: THE CUSTOMER COMPLAINT OF UNEXPECTED ALERT/ALARM IS CONFIRMED. BECAUSE THE SENSOR WAS ALREADY OPENED OR USED WHEN WE RECEIVED IT FOR TESTING, IT IS IMPOSSIBLE TO DETERMINE WHEN OR HOW THIS (SENSOR FLEX DAMAGE) HAPPENED. 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

    T WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED MULTIPLE SENSOR-RELATED ISSUES, INCLUDING "CHANGE SENSOR," "SENSOR UPDATING," A BENT SENSOR, BLOOD AT THE INSERTION SITE, SG VS BG DISCREPANCIES, AND HIGH BLOOD GLUCOSE (BG). THE EVENT INVOLVED PRODUCT(S) MMT-5120A,MMT-1884,MMT-431AK,MMT-342. THE SENSOR GLUCOSE (SG) VALUE WAS 238 MG/DL AND BLOOD GLUCOSE (BG) WAS 281 MG/DL, WHICH IS WITHIN THE TARGET RANGE. THE CUSTOMER REPORTED A SMALL AMOUNT OF BLOOD AT THE UPPER ARM SENSOR INSERTION SITE BUT NO ACTIVE OR EXCESSIVE BLEEDING. THE SENSOR FILAMENT HAD A SLIGHT BEND, WHICH IS CONSIDERED NORMAL AS THE FILAMENT IS DESIGNED TO BE FLEXIBLE. THE CUSTOMER ALSO REPORTED A HIGH BG EVENT AND MANAGED IT BY BOLUSING WITH THE PUMP. NO FURTHER CUSTOMER COMPLICATIONS WERE REPORTED. MMT-5120A WAS EXPECTED TO RETURN. MMT-1884,MMT-431AK,MMT-342 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
    380878 SENSOR MMT-5120A SIMPLERA SYNC 5PK US SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120A HG97HE6 000020763000956381

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male