BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120C INSTINCT 780 5PK OUS 1

    MDR report key: 23445296 · Received November 3, 2025

    Report

    Report Number
    2032227-2025-294043
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 23, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE FOLLOWING: PARTIAL ONE OPENED/USED SIMPLERA SENSOR, ONE SIMPLERA SERTER WAS NOT RETURNED, 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 CRACKS ALONG THE GOLD TRACE PATH. CHECKED THE TRANSMITTER CASING FOR ANY PHYSICAL/COSMETIC DAMAGE AND 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: SENSOR DEHYDRATION. FIRST TERM REASON DESCRIPTOR: THE SENSOR WAS TERMINATED BECAUSE IT WAS REMOVED FROM THE BODY PRIOR TO THE DEVICE'S END OF LIFE. THE DEHYDRATION CAN BE CAUSED BY MULTIPLE FACTORS. IT IS UNKNOWN THAT THE SENSOR CONTRIBUTED TO THE EVENT. IN CONCLUSION: THE CUSTOMER COMPLAINT OF SG V BG IS NOT 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.

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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, DIFFERENCES BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE VALUE. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 57 MG/DL AND SENSOR GLUCOSE VALUE OF 98 MG/DL AT THE TIME OF EVENT. HYPOGLYCEMIC EVENT WAS TREATED WITH GLUCOSE/CARB INTAKE. THE EVENT INVOLVED PRODUCT MMT-5120C1. TROUBLESHOOTING WAS PERFORMED, AND THE DIFFERENCE BETWEEN THE SENSOR GLUCOSE AND THE BLOOD GLUCOSE WAS NOT WITHIN THE ACCEPTABLE RANGE. INSULIN DELIVERY WAS NOT SUSPENDED. CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED EVENT. CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-5120C1 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480496 SENSOR MMT-5120C INSTINCT 780 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-5120C1

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown