BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 22401838 · Received July 4, 2025

    Report

    Report Number
    2032227-2025-204225
    Event Type
    Malfunction
    Date Received
    July 4, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 3, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    (B)(6) 2025 15:35:28 DOP114-980DOC_VER_AZ: BUMPED/DROPPED/COSMETIC DAMAGE CUSTOMER REPORTED PUMP WAS DROPPED/BUMPED AND/OR PUMP HAS POSSIBLE PHYSICAL OR COSMETIC DAMAGE. 06/09/2025 15:35:28 DOP114-980DOC_VER_AZ: KEYPAD ANOMALY/STUCK BUTTON ALARM CUSTOMER REPORTED A KEYPAD ANOMALY AND/OR STUCK BUTTON ALARM. 06/09/2025 15:35:28 DOP114-980DOC_VER_AZ: LOW/SHORT BATTERY LIFETIME CUSTOMER REPORTED A SHORT BATTERY LIFE OR A LOW BATTERY ALARM. 06/09/2025 15:35:28 DOP114-980DOC_VER_AZ: TAPE NOT STICKING CUSTOMER REPORTED AN ISSUE WITH THE SENSOR TAPE STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152962 PUMP MMT-1884L MM780G BLE 3.0 MG/ML AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3544559H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female