BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 23178150 · Received September 30, 2025

    Report

    Report Number
    2032227-2025-272465
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 26, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO VERIFY FAILED BATTERY ALERT/BATTERY FAILED ALARM, FLASHING MEDTRONIC LOGO AND PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. INSERT BATTERY ALARM WAS FOUND ON: 09/08/2025 18:03:57.000. LOW BATTERY ALERT WAS FOUND ON: 09/08/2025 18:03:57.000. 09/09/2025 17:36:00.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UNABLE TO TEST FOR LOW BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOW BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE UNKNOWN. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS DUE TO MAIN LCD TEST FAILURE (0X00000049) IN THE BOOTLOADER ACCORDING IN THE ERROR LOG FILE, SUSPECTED ON HW. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 09-SEP-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: PUMP ERROR 130 ALARM WAS FOUND ON: 09/09/2025 17:47:19.000, 09/09/2025 17:47:24.000. 09/09/2025 17:48:36.000, 09/09/2025 17:48:41.000 UNABLE TO TEST FOR PUMP ERROR 130 ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP ERROR 130 ALARM WAS UNKNOWN. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. UNABLE TO VERIFY FAILED BATTERY ALERT/BATTERY FAILED ALARM, FLASHING MEDTRONIC LOGO AND PERFORM THE REQUIRED TESTING DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. CORROSION WAS ALSO FOUND ON THE FORCE SENSOR AND MOTOR ASSEMBLY NOTED. 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

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 A FLASHING MEDTRONIC LOGO ON THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880L. TROUBLESHOOTING WAS PERFORMED FOR THE FLASHING MEDTRONIC LOGO AND THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED AND INSTRUCTED TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS AND PLACE PUMP IN STORAGE MODE. TROUBLESHOOTING WAS PARTIALLY PERFORMED FOR THE BATTERY FAILED ALARM AS THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1880L WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154825 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG4086192H

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male