BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SENSOR 3

    MDR report key: 23614282 · Received November 21, 2025

    Report

    Report Number
    2032227-2025-304182
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    June 11, 2023
    Report Date
    November 20, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300033699801
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. FOLLOWING OUR RECEIPT OF THE ONE RETURNED USED SENSOR PERFORMED A VISUAL INSPECTION AND CHECKED FOR PHYSICAL DAMAGE AND FOUND AT THE REFERENCE ELECTRODE PLATINUM OVERGROWN, THEN FOUND THE GOLD PLATING TO BE BENT (CRACKS ALONG THE GOLD PATH). THEN PERFORMED CONTINUITY RESISTANCE TEST TO VERIFY (OPEN TRACE), ELECTRICAL INTERRUPTION IN THE SENSOR CIRCUIT AND SENSOR PASSED PER SPECIFICATION. PERFORMED BICARBONATE BUFFER TEST AND SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. SEE ATTACHED FILE FOR RESULTS. IN SUMMARY, SENSOR PASSED PER SPECIFICATIONS SUBMERGE SENSOR UNDER DIFFERENT LEVELS OF GLUCOSE AND SENSOR PASSED WITH ACCURATE READINGS. UNABLE TO CONFIRM CUSTOMER COMPLAINT OF UNEXPECTED ALERT/ALARM, AND (SG V BG). 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 DIFFERENCE BETWEEN CALIBRATION ALERT, CHANGE SENSOR ALERT, DIFFERENCE BETWEEN SENSOR AND BLOOD GLUCOSE VALUES. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7020LB. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE AT THE TIME OF EVENT WAS 176 MG/DL. THE CUSTOMER REPORTED SENSOR GLUCOSE VALUE AT THE TIME OF EVENT WAS 70 MG/DL. CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SENSOR AND BLOOD GLUCOSE VALUES WHICH WAS NOT WITHIN RANGE. EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED THE USE OF THE DEVICE.MMT-7020LB WAS REQUESTED AND CUSTOMER RESPONDED THE DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464088 GUARDIAN SENSOR 3 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020LB HG6ZEUT 000076300033699801

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female