BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1

    MDR report key: 21266487 · Received January 29, 2025

    Report

    Report Number
    2032227-2025-117974
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 29, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    UDI-DI
    000020763000712475
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    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 SENSOR GLUCOSE (SG) VS. BLOOD GLUCOSE (BG), UNEXPECTED SUSPEND [LOW SG], CHANGE SENSOR ALERT, CALIBRATION NOT ACCEPTED ALERT. THE CUSTOMER REPORTED HEMORRHAGE/BLOOD LOSS/BLEEDING INVOLVED NO TREATMENT AND HYPERGLYCEMIA TREATED BY INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 290 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-7040C1. TROUBLESHOOTING WAS PERFORMED FOR SG VS BG GUARDIAN SENSOR 3/GUARDIAN 4 SENSOR. CUSTOMER HAS REPORTED A DISCREPANCY BETWEEN SG AND BG WHICH IS NOT WITHIN RANGE. SG VALUE THAT TRIGGERED THE SUSPEND ON LOW/SUSPEND BEFORE LOW EVENT: BELOW 50MG/DL G VALUE ASSOCIATED WITH THE TRIGGERED SUSPEND EVENT: 120MG/DL. EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES AND EXPLAINED POSSIBLE CAUSES. TROUBLESHOOTING WAS PERFORMED FOR CHANGE SENSOR/SENSOR UPDATING/SG VALUE NOT AVAILABLE/CALIBRATION NOT ACCEPTED. CUSTOMER RECEIVED A CHANGE SENSOR ALERT AND CALIBRATION NOT ACCEPTED ALERT. CUSTOMER IS UNABLE TO RUN A TRANSMITTER TEST AND/OR TEST PASSED. CUSTOMER WAS ADVISED TO TRY ANOTHER SENSOR. TROUBLESHOOTING WAS PERFORMED FOR SITE ISSUES. CUSTOMER REPORTED BLOOD AT SITE. TROUBLESHOOTING WAS PARTIALLY PERFORMED FOR HIGH BLOOD GLUCOSE (BGS)/UNDER DELIVERY AS CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. CUSTOMER REPORTED HIGH BGS. CUSTOMER HAS USED THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED HIGH BG EVENT. THE CUSTOMER HAS NOT USED THE SMARTGUARD/AUTO MODE OF THE INSULIN PUMP AT THE TIME OF REPORTED HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED FOR SUSPEND ON LOW/SUSPEND BEFORE LOW. CUSTOMER HAD QUESTION OR CONCERN OF SUSPEND ON LOW/SUSPEND BEFORE LOW FEATURE. CUSTOMER INQUIRED ABOUT WHAT WOULD HAPPEN TO SUBSEQUENT ALARMS WHILE PUMP IS IN SUSPEND EVENT. EXPLAINED ALARMS WILL QUEUE AND ARE DISPLAYED ONCE CUSTOMER SELECTS DISMISS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PRODUCT RETURN FOR MMT-7040C1 IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507070 SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040C1 D2224 000020763000712475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown