BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 23627034 · Received November 23, 2025

    Report

    Report Number
    2032227-2025-305292
    Event Type
    Malfunction
    Date Received
    November 23, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE ISSUE WAS NOT PERFORMED AS TESTING OR REPRODUCTION WOULD NOT YIELD RESULTS THAT WOULD CONFIRM OR DENY THE ISSUE. INSTEAD THIS ISSUE WOULD BE INVESTIGATED THROUGH DATABASE APPLICATION LOGS. THIS ISSUE IS CONFIRMED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SW REQUIREMENT DOC FIELD. AFTER A THOROUGH INVESTIGATION THE SOFTWARE SUPPORT TEAM HAS CONFIRMED THE MEAL PERIODS DINNER AND OVERNIGHT MEAL PERIODS ARE OVERLAPPING. THE MOST LIKELY ROOT CAUSE IS THE MEAL PERIODS DINNER AND OVERNIGHT MEAL PERIODS ARE OVERLAPPING. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, MEDTRONIC PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: CAN THE PATIENT TRY ADJUSTING THE MEAL PERIOD OF DINNER AND OVERNIGHT. PLEASE ASK THE PATIENT TO ADJUST THE MEAL PERIODS SO THAT THE DINNER AND OVERNIGHT MEAL PERIODS DO NOT OVERLAP. FOR EG: ADJUST DINNER PERIOD TO END AT 22:00 AND OVERNIGHT MEAL PERIOD TO START FROM 23:00. THE HELPLINE HAS NOT YET CONFIRMED WHETHER THE RECOMMENDED STEPS HAVE SUCCESSFULLY RESOLVED THE ISSUE. 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 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 UNABLE TO GENERATE REPORTS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7333. TROUBLESHOOTING WAS PERFORMED. UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS NOT APPLICABLE FOR NON PHYSICAL DEVICE MMT-7333.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555399 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown