BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7040A GUARDIAN4 5PK US

    MDR report key: 23376480 · Received October 24, 2025

    Report

    Report Number
    2032227-2025-289659
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 13, 2024
    Report Date
    October 23, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    002076300041338901
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS 2 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 HYPOGLYCEMIA, LOSS OF CONSCIOUSNESS, HYPOGLYCEMIC SHOCK, SEIZURES, ABSENCE TREATED WITH DISCONTINUED USE OF INSULIN DELIVERY SYSTEM, GLUCOSE/CARB INTAKE, EMERGENCY ROOM VISIT, NO TREATMENT, AND GLUCOSE/CARB INTAKE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 21 MG/DL AT THE EMERGENCY MEDICAL SERVICES DISPATCHED AND 81MG/DL EMERGENCY ROOM VISIT. THE CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: NO TROUBLESHOOTING WAS IDENTIFIED. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-396A, MMT-7040A, MMT-1884L. THE CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE WHICH IS NOT WITHIN RANGE. THE EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES. THE CUSTOMER HAS NOT BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BLOOD GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN WAS REQUIRED FOR MMT-332A. NO PRODUCT RETURN WAS REQUIRED FOR MMT-396A. NO PRODUCT RETURN WAS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN WAS REQUIRED FOR MMT-1884L. UPDATED SUMMARY:IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMERS WIFE CALLED EMERGENCY MEDICAL SERVICES AND THAT THEY WERE DISPATCHED AND THAT THEY WENT TO THE EMERGENCY ROOM ON SEP. 13, 2024 AT 8:30AM DUE TO HYPOGLYCEMIA. A SEIZURE WAS ALSO MENTIONED. BLOOD GLUCOSE AT TIME WITH EMS WAS 21 MG/DL. BLOOD GLUCOSE AT TIME OF ER VISIT WAS 81 MG/DL. USER ALSO TREATED WITH APPLE JUICE, A GRAHAM CRACKER AND PEANUT BUTTER. USER WAS GIVEN INSULIN DRIP WHILE AT THE HOSPITAL. WHEN ASKED WHAT LED TO THE EVENT, THEY STATED SG V BG VALUE DIFFERENCES. CUSTOMER STATED PUMP DATE AND TIME WERE WRONG AT TIME OF THE CALL. DATE SHOWED SEP. 11, 2024 HOWEVER IT WAS CORRECTED TO SEP. 13, 2024. WHEN ASKED IF PATIENT TAKES MEDICATION SUCH AS ACETAMINOPHEN, PARACETAMOL, OR HYDROXYUREA (ALSO KNOWN AS HYDROXYCARBAMIDE) THEY STATED YES. IT WAS CLARIFIED THAT USER WAS TAKING TYLENOL (ACETAMINOPHEN).UPDATED SUMMARY:IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA, LOSS OF CONSCIOUSNESS, HYPOGLYCEMIC SHOCK, SEIZURES, ABSENCE TREATED WITH DISCONTINUED USE OF INSULIN DELIVERY SYSTEM, GLUCOSE/CARB INTAKE, EMERGENCY ROOM VISIT, AND GLUCOSE/CARB INTAKE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 45 MG/DL AND SENSOR GLUCOSE VALUE AS 155 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-396A, MMT-7040A, MMT-1884L. TROUBLESHOOTING WAS PERFORMED AND FOUND THE CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE WHICH IS NOT WITHIN RANGE. THE EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES. THE CUSTOMER HAS NOT BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BLOOD GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN WAS REQUIRED FOR MMT-332A. NO PRODUCT RETURN WAS REQUIRED FOR MMT-396A. NO PRODUCT RETURN WAS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN WAS REQUIRED FOR MMT-1884L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223078 SENSOR MMT-7040A GUARDIAN4 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7040A HG7X00K 002076300041338901

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention FRN-MMT-332A-RSVR, UNOMED INF SET