BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN SENSOR 3

    MDR report key: 22738264 · Received August 7, 2025

    Report

    Report Number
    2032227-2025-230498
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    August 2, 2023
    Report Date
    August 7, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING OUR RECEIPT OF THE ONE RETURNED USED PARTIAL SENSOR (NEEDLE NOT RETURNED) AND PERFORMED A VISUAL INSPECTION AND CHECKED FOR PHYSICAL DAMAGE AND NONE WAS FOUND (UNDER NAKED EYE) 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 FAILED PER SPECIFICATIONS DUE TO LOW READINGS, PLACE SENSOR UNDER MICROSCOPE AND FOUND GOLD TRACE DAMAGE AT THE REFERENCE AND COUNTER ELECTRODE AND PLATINUM OVERGROWTH AT THE REFERENCE ELECTRODE. SEE ATTACHED FILE FOR DETAILS. IN SUMMARY, THE CUSTOMER COMPLAINT OF SG V BG EVENT WAS CONFIRMED, FOUND SENSOR FLEX DAMAGE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 411 MG/DL AT THE TIME OF THE EVENT. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND THE CUSTOMER EXPERIENCED SYMPTOMS OF VOMITING, THIRST AND SITE IRRITATION. TROUBLESHOOTING WAS PERFORMED AND FOUND SODA POP SIZE AIR BUBBLES IN THE TUBING, FOUND SENSOR GLUCOSE & BLOOD GLUCOSE DIFFERENCE WHEREIN, THE INSULIN DELIVERY WAS NOT SUSPENDED. CUSTOMER WAS USING INSULIN PUMP WITHIN 48 HOURS PRIOR TO EVENT AND AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP AND IT WILL NOT BE RETURNED FOR ANALYSIS. FRN-MMT-332-RSVR, UNOMED INF SET, OZP-MMT-7020- SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501091 GUARDIAN SENSOR 3 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020LA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other