BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020C1 GS3 5PK 9L OUS1

    MDR report key: 24906363 · Received April 17, 2026

    Report

    Report Number
    2032227-2026-161834
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 (UPDATED THE SUMMARY) WITH THIS REPORT. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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

    UPDATED SUMMARY: AS PER THE ADDITIONAL INFORMATION RECEIVED, BLOOD GLUCOSE VALUE WAS 121 MG/DL, SENSOR GLUCOSE VALUE WAS 40 MG/DL AND THE DIFFERENCE BETWEEN BOTH THE VALUES WAS WITHIN THE ACCEPTABLE RANGE. SO, THE EVENT SUBMITTED UNDER REGULATORY REPORT NUMBER 2032227-2026-161834 IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA DUE TO DISCREPANCY IN READING BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES. THE EVENT INVOLVED PRODUCT(S) MMT-7020C1. TROUBLESHOOTING WAS PERFORMED AND IT WAS DETERMINED THAT THE DISCREPANCY BETWEEN THE SENSOR GLUCOSE VALUE OF 121 MG/DL AND THE CORRESPONDING BLOOD GLUCOSE VALUE OF 40 MG/DL EXCEEDED THE ACCEPTABLE RANGE. THE CUSTOMER FURTHER REPORTED THAT INSULIN DELIVERY WERE SUSPENDED DURING THIS PERIOD. THE CUSTOMER WAS INFORMED THAT THE SENSOR MAY NO LONGER BE RESPONDING TO GLUCOSE CHANGES, AND POSSIBLE CAUSES WERE EXPLAINED. NO FURTHER PATIENT COMPLICATION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7020C1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123147 SENSOR MMT-7020C1 GS3 5PK 9L OUS1 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020C1 HG8M3GY

    Patients

    Seq Age Sex Outcome Treatment
    1