BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 22870081 · Received August 22, 2025

    Report

    Report Number
    2032227-2025-242423
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 13, 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 CONFIRMED PATIENT DID TIME CHANGE ON JULY 2ND AND JULY 3RD. THIS IS THE REASON THERE IS A DISCREPANCY IN THE DATES AND THE REPORTS. PATIENT HAS CORRECTED THE TIME FROM JULY 5TH. THE DATA WITH INCORRECT PUMP TIME IS CORRUPTED AND REPORTS FOR THOSE DATES CANNOT BE RETRIEVED. THE MOST LIKELY ROOT CAUSE IS THE PATIENT DID TIME CHANGE ON JULY 2ND AND JULY 3RD. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: PATIENT DID TIME CHANGE ON JULY 2ND AND JULY 3RD. THIS IS THE REASON THERE IS A DISCREPANCY IN THE DATES AND THE REPORTS. PATIENT HAS CORRECTED THE TIME FROM JULY 5TH. THE DATA WITH INCORRECT PUMP TIME IS CORRUPTED AND REPORTS FOR THOSE DATES CANNOT BE RETRIEVED. PLEASE ASK THE PATIENT TO GENERATE REPORTS FROM JULY 5TH. THE CUSTOMER IS SEEING AUGUST 2ND BECAUSE ON JULY 2ND THEY DID A TIME CHANGE IN THE PUMP AND SET IT TO AUGUST 2ND, THE DATA UPLOADED ON JULY 2ND WE' BE STORED AS DATA FOR AUGUST 2ND. THIS IS WHY REPORT IS SHOWN FOR THAT DATE. THIS CANNOT BE CORRECTED. THE DATA ON AUGUST 2ND TO AUGUST 3RD IS CORRUPTED AND IT CAN NOT BE RETRIEVED. THE PATIENT CAN GENERATE REPORTS FROM AUGUST 4TH. DO NOT INCLUDE THE CORRUPTED DATE IN THE DATE RANGE. THE HELPLINE HAS PROVIDED US WITH FEEDBACK REGARDING THE OUTCOME OF THE RESOLUTION STEPS IMPLEMENTED AND HAS CONFIRMED THE ISSUE HAS BEEN SUCCESSFULLY RESOLVED. 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 EXPERIENCED A REPORT ANOMALY AS THE GENERATED REPORT HAVING INCORRECT DATES. 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. A PRODUCT RETURN IS NOT APPLICABLE FOR NON PHYSICAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661312 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown