BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020MLA GS3 5PK 2L US

    MDR report key: 23022739 · Received September 10, 2025

    Report

    Report Number
    2032227-2025-256256
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    May 31, 2023
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MDS
    UDI-DI
    002076300051623301
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. ON 31/05/2023 CUSTOMER ALLEGED RECEIVED UNEXPECTED ALERT/ALARM (SG V BG), ALSO FOUND ELECTRODE BENT. FOLLOWING OUR RECEIPT OF THE ONE RETURNED USED SENSOR PERFORMED A VISUAL INSPECTION AND CHECKED FOR PHYSICAL DAMAGE AND FOUND A SENSOR ELECTRODE TO BE BENT WITHOUT ANY DAMAGE. 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. BENT CANNULA DID NOT AFFECT THE SENSOR'S PERFORMANCE. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. 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 THE MEDTRONIC MINIMED THAT THE CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE WHICH IS NOT WITHIN RANGE. CUSTOMER REPORTED RECEIVING CHANGE SENSOR AND CALIBRATION NOT ACCEPTED ALERTS AND ALSO FOUND BENT SENSOR. EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES AND EXPLAINED POSSIBLE CAUSES. NO ADVERSE EVENT HAS BEEN REPORTED. THE EVENT INVOLVED PRODUCTS ARE MMT-7020LA. PRODUCT HAS BEEN RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330986 SENSOR MMT-7020MLA GS3 5PK 2L US SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020MLA HG6HJE6 002076300051623301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown