BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120MA SIM SYNC 5PK MED US

    MDR report key: 25107875 · Received May 6, 2026

    Report

    Report Number
    2032227-2026-170656
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. 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 RECEIVED PUMP ERROR 55 (THE FLASH CRC IS INCORRECT FOR FACTORY-STORED INFORMATION.) AND EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER REPORTED HYPERGLYCEMIA WAS TREATED WITH AN INSULIN PUMP AND MANUAL INJECTION. THE EVENT INVOLVED PRODUCT(S) 2 X MMT-5120MA, MMT-18844L, MMT-332A, MMT-397A, MMT-6102. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED A LOSS OF COMMUNICATION BETWEEN THE SENSOR AND THE PUMP. THE CUSTOMER REPORTED A LOSS COMMUNICATION OF PUMP AND MOBILE. THE CUSTOMER REPORTED AN ISSUE WITH THE SENSOR TAPE STICKING. THE CUSTOMER REPORTED RECEIVING A CHANGE SENSOR ALERT. THE CUSTOMER REPORTED A DISCREPANCY BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. NO PRODUCT RETURN IS REQUIRED FOR 2 X MMT-5120MA, MMT-332A, MMT-397A, MMT-6102. MMT-1884L WAS REQUESTED, AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494528 SENSOR MMT-5120MA SIM SYNC 5PK MED US SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120MA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male