BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7040A GUARDIAN4 5PK US

    MDR report key: 20964233 · Received December 18, 2024

    Report

    Report Number
    2032227-2024-289229
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 12, 2024
    Report Date
    October 17, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN BELOW SECTION WITH THIS REPORT. B1(ADVERSE EVENT)-SELECTED. B2(OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) -SELECTED. B5-UPDATED THE SUMMARY WITH RESPECT TO ADVERSE EVENT AND DEVICE ALLEGATION. D10 (CONCOMITANT MEDICAL PRODUCTS) -ADDED. H1/H2(TYPE OF REPORTABLE EVENT) - SELECTED "SERIOUS INJURY". H6-(HEALTH EFFECT CLINICAL CODE/HECC) CHANGED FROM 4582 TO 1905 AND HEALTH EFFECT IMPACT. CODE(HEIC) CHANGED FROM 2199 TO 4613. 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 DISCREPANCY BETWEEN SENSOR GLUCOSE VALUES AND BLOOD GLUCOSE VALUES. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040A. TROUBLESHOOTING WAS PERFORMED AND CONFIRMED CUSTOMER RECEIVED THE REPORTED ISSUE DISCREPANCY BETWEEN SENSOR GLUCOSE VALUES AND BLOOD GLUCOSE VALUES WHICH IS NOT WITHIN RANGE. INSULIN DELIVERY WAS SUSPENDED DUE TO DIFFERENCE BETWEEN SENSOR GLUCOSE VALUES AND BLOOD GLUCOSE VALUES. EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER CONTINUED USING THE DEVICE OR NOT. PRODUCT RETURN REQUESTED FOR MMT-7040A. CUSTOMER DECLINED TO RETURN, OR IS UNABLE TO RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER ALSO NOTICED A SIGNIFICANT DISCREPANCY BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES THAT TRIGGERED A THRESHOLD SUSPENSION. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 429MG/DL. THE HYPERGLYCEMIA WAS TREATED WITH A MANUAL INJECTION/INSULIN PEN. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-1884, MMT-332A AND UNOMEDICAL. TROUBLESHOOTING WAS NOT PERFORMED FOR HYPERGLYCEMIA. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT AND IT WAS UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED FOR DIFFERENCE BETWEEN GLUCOSE VALUES. THE CUSTOMER REPORTED A SENSOR GLUCOSE VALUE WAS 50MG/DL AT THE TIME OF INCIDENT. THE DIFFERENCE BETWEEN GLUCOSE VALUES WERE OUTSIDE THE ACCEPTABLE RANGE. INSULIN DELIVERY WAS SUSPENDED AND NON-SERIALIZED PRODUCT BEING REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720761 SENSOR MMT-7040A GUARDIAN4 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7040A HG7QRZ9

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET.