BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 24613931 · Received March 16, 2026

    Report

    Report Number
    2032227-2026-145134
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000076300031665503
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (B)(6) 2026 07:54:40 (B)(4) _VER_BC: BUMPED/DROPPED/COSMETIC DAMAGE CUSTOMER REPORTED PUMP WAS DROPPED/BUMPED AND/OR PUMP HAS POSSIBLE PHYSICAL OR COSMETIC DAMAGE. ON (B)(6) 2026 07:54:40 (B)(4) _VER_BC: KEYPAD ANOMALY/STUCK BUTTON ALARM CUSTOMER REPORTED A KEYPAD ANOMALY AND/OR STUCK BUTTON ALARM. ON (B)(6) 2026 07:54:40 (B)(4) _VER_BC: BATTERY FAILED ALARM CUSTOMER REPORTED RECEIVING A BATTERY FAILED ALARM. ON (B)(6) 2026 07:54:40 (B)(4) _VER_BC: INSULIN FLOW BLOCKED ALARM CUSTOMER REPORTED A PAST INSULIN FLOW BLOCKED ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674715 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL NG3987827H 000076300031665503

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male