BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 24001539 · Received January 8, 2026

    Report

    Report Number
    2032227-2026-103704
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 15, 2025
    Report Date
    April 1, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT WAS MADE TO REPRODUCE THE ISSUE USER REPORTED BY GENERATING THE LOG BOOK REPORT. THE GENERATED LOG BOOK REPORT CALCULATIONS ARE AS EXPECTED AND DIDN'T FIND ANY ISSUE. THE REPORTED EVENT WAS CONFIRMED BUT THIS IS AN EXPECTED BEHAVIOR. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT LISTED BELOW UNDER SW REQUIREMENT DOC. USER'S CONCERN WAS NOT ABLE TO SEE ALL BG (BLOOD GLUCOSE) IN LOG BOOK REPORT, IT IS OBSERVED THAT THE VALUE IN THE CELL 2AM TO 3AM HAS 2 BG VALUES THIS IS INDICATED BY THE ASTERISK AT THE TOP OF THE NUMBER , HENCE BOTH THE NUMBERS ARE NOT DISPLAYED ON THE REPORT THIS IS MENTIONED IN THE REPORT LEGEND. THE SUMMARY OF THE DAY WILL SHOW THE TOTAL NUMBER OF BG'S. AS PER THE SOFTWARE SPECIFICATION REQUIREMENTS , IT IS EXPECTED TO ASTERISK AT THE TOP OF THE NUMBER IF MORE THAN 1 BG PRESENT. STEPS FOR RECOMMENDATION: FOR IN DEEPER THERAPY ANALYSIS, WOULD LIKE TO RECOMMEND GENERATING DAILY REPORT THAT SHOWS BG CALIBRATIONS IF ANYTHING PRESENT AND ALSO GENERATE ADHERENCE REPORT TO SEE THE SUMMARY OF EVENTS FOR EACH DAY AND WEEKLY STATISTICS OF THE EVENTS. THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS DUE TO LACK OF USER TRAINING. 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

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 ISSUE WITH LOGBOOK REPORT. THE ISSUE WAS NOT PRESENT IN EVERY DAY BUT MOST OF THE DAYS IN THE PERIOD OF THE LAST 90 DAYS WERE MISSING THE BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7333. TROUBLESHOOTING WAS PERFORMED AND IT WAS UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7333.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62295 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown