BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 22050289 · Received May 20, 2025

    Report

    Report Number
    2032227-2025-177694
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 23, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300058619502
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Additional Manufacturer Narrative · 0

    ALL BUTTONS FUNCTION PROPERLY, AND NO ANOMALY NOTED. PUMP PASSED THE DISPLACEMENT TEST, SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED, NO DELIVERY ALARM, BUTTON KEYPAD ANOMALY, REWIND ANOMALY NOTED DURING TESTING. THUS, SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. ALARMED NO DELIVERY SHOW IN THE TRACE/HISTORY FILES ON (B)(6) 2025 08:16:43.000, (B)(6) 2025 08:17:03.000, (B)(6) 2025 08:20:57.000, (B)(6) 2025 08:25:38 DURING BOLUS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND NO COMPONENT OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, KEYPAD ASSEMBLY, MOTOR ASSEMBLY AND FORCE SENSOR. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY AND NO ANOMALY NOTED. UNIT HAD SCRATCHED CASE, STAINED KEYPAD OVERLAY. ALL BUTTONS FUNCTION PROPERLY. PUMP PASSED ALL TESTING REQUIRED AND INSULIN FLOW BLOCKED/NO DELIVERY ALARM, BUTTON KEYPAD ANOMALY, REWIND ANOMALY NOT CONFIRMED. 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 EXPERIENCED DELIVERY WAS STOPPED ONE TIME AND REPLACED THE BATTERY IT WORKED, REWINDING ON THE PUMP WAS LOUDER, BUTTONS WERE OCCASIONALLY HARDER TO PRESS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1880L. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN WAS REQUIRED FOR MMT-1880L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129775 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3832438H 000076300058619502

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female