BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 24327731 · Received February 12, 2026

    Report

    Report Number
    2032227-2026-125966
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 12, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    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. 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

    ON 01/28/2026 17:12:00 (B)(4): BATTERY FAILED ALARM CUSTOMER REPORTED RECEIVING A BATTERY FAILED ALARM. NO DAMAGE REPORTED TO BATTERY CAP CONTACTS OR BATTERY COMPARTMENT. CUSTOMER DID NOT RECEIVE ANOTHER ALARM AFTER REPLACING BATTERY. 01/28/2026 17:12:00 (B)(4): DISPLAY - FLASHING/WHITE/BLANK/FROZEN/PARTIAL CUSTOMER REPORTED A BLANK DISPLAY. BATTERY CAP CONTACTS AND BATTERY COMPARTMENT AND/OR SPRINGS ARE NOT DAMAGED. DISPLAY DID NOT RETURN AFTER INSERTING A NEW BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388731 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL NG3216764H 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male