BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 22822872 · Received August 16, 2025

    Report

    Report Number
    2032227-2025-236992
    Event Type
    Malfunction
    Date Received
    August 16, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 19, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300057864002
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT TEST AND ACTIVE CURRENT MEASUREMENT TEST. ALL CURRENTS WITHIN SPEC RANGE. THE PUMP WAS MONITORED AND NO UNEXPECTED POWER LOSS NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP SOFTWARE. POWER MANAGEMENT TOOL CONFIRMED UNLOADED VLITH VOLTAGE AND LOADED VLITH VOLTAGE IS WITHIN SPECS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE BATTERY TUBE ASSEMBLY NOTED. BATTERY CYCLE 43.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 15:35:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 40.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 15:21:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 35.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 15:11:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 18.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 14:58:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 17.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 14:55:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 15.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 14:52:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 13.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/21/2025 14:44:00 FASTER THAN EXPECTED AT 0.0 DAYS. IN SUMMARY, CUSTOMER ALLEGED BATTERY POWER LOSS CONFIRMED. WITH REFERENCE TO THE BAAT TOOL INSTRUCTIONS, CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. CHARGE/BATTERY LASTS LESS THAN EXPECTED 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.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 RECEIVED A BATTERY FAILED ALARM, SHORT BATTERY LIFE, AND HAD A REPLACE BATTERY ALERT. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880L. TROUBLESHOOTING WAS PERFORMED FOR THE REPLACE BATTERY ALERT, AND THE SERIALIZED DEVICE WAS REPLACED. TROUBLESHOOTING WAS PERFORMED FOR THE SHORT BATTERY LIFETIME, AND NO ALARM WITH BATTERY OUT. TROUBLESHOOTING WAS PERFORMED FOR THE BATTERY FAILED ALARM, AND NO DAMAGE WAS REPORTED TO THE BATTERY CAP CONTACTS OR THE BATTERY COMPARTMENT. THE CUSTOMER DID NOT RECEIVE ANOTHER ALARM AFTER REPLACING THE BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-1880L WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457228 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG4003077H 000076300057864002

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male