BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 22824217 · Received August 17, 2025

    Report

    Report Number
    2032227-2025-237525
    Event Type
    Malfunction
    Date Received
    August 17, 2025
    Date of Event
    July 19, 2025
    Report Date
    October 23, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300081938501
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF TEST. NO BLANK DISPLAY NOTED DURING TESTING. NO EXPECTED BATTERY ALERTS NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS OR ALERTS NOTED DURING TESTING. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND: LOW BATTERY ALARMS ON 07/19/2025 03:12:00, 07/16/2025 11:47:00 AND 07/14/2025 03:41:00 AND FAILED BATTERY TEST ALERTS ON 07/16/2025 11:52:40, 07/16/2025 11:53:01, 07/16/2025 11:53:32, 07/16/2025 11:53:53, 07/16/2025 11:54:20, 07/16/2025 11:55:25, 07/16/2025 11:55:45 AND 07/19/2025 13:46:37. BATTERY CYCLE 39.0 RECEIVED THE LOW BATTERY ALERT (104) ON 07/19/2025 03:12:00 FASTER THAN EXPECTED AT 2.63 DAYS. BATTERY CYCLE 30.0 RECEIVED THE LOW BATTERY ALERT (104) ON 07/16/2025 11:47:00 FASTER THAN EXPECTED AT 2.21 DAYS. BATTERY CYCLE 20.0 RECEIVED THE LOW BATTERY ALERT (104) ON 07/14/2025 03:41:00 FASTER THAN EXPECTED AT 2.26 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, THE CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND CRACKED CASE-CORNER OF BELT CLIP RAILS. CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. UNEXPECTED BATTERY POWER LOSS AND CHARGE/BATTERY LASTS LESS THAN EXPECTED WERE CONFIRMED, SUSPECTING HARDWARE ISSUE. PROBLEM ISOLATED ELECTRONIC STACK. BLANK DISPLAY WAS NOT OBSERVED DURING ANALYSIS AND PASSED ALL REQUIRED TESTING. BLANK DISPLAY AND FAILED BATTERY TEST WERE 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.

    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 STATED THAT THE PUMP'S BATTERY WAS NOT WORKING AND ALSO MENTIONED THAT THE PUMP SCREEN WAS COMPLETELY BLANK. THE CUSTOMER HAD RECEIVED THE 'REPLACE BATTERY NOW' ALARM, FOLLOWED BY A 'LOW BATTERY' ALERT. THE PUMP DID NOT ACCEPT A NEW BATTERY.THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. TROUBLESHOOTING WAS PERFORMED FOR REPLACE BATTERY NOW ALARM AND CUSTOMER REPORTED RECEIVING REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WITHOUT RECEIVING A LOW BATTERY WARNING FIRST. THIS WAS THE FIRST OCCURRENCE. BATTERY CAP WAS NOT DAMAGED AND BATTERY WAS NOT USED IN ANOTHER DEVICE FIRST. TROUBLESHOOTING WAS PERFORMED FOR POWER LOSS ALARM. CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED FOR DISPLAY ISSUE AND CUSTOMER STATED THAT THE BATTERY CAP CONTACTS AND BATTERY COMPARTMENT AND/OR SPRINGS WERE NOT DAMAGED. THE CUSTOMER WAS USING THE CORRECT BATTERY CAP FOR THE PUMP, INSERTED A NEW BATTERY AND RESTARTED THE INSULIN PUMP BUT THE DISPLAY DID NOT RETURN. 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-1884L 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
    1646787 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 NG3833610H 000076300081938501

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female