BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 22952247 · Received September 3, 2025

    Report

    Report Number
    2032227-2025-251163
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 3, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300081937801
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS 1 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0869 INCHES. NO PUMP ERROR 37 OR PUMP ERROR 130 NOTED DURING TESTING. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, LOST SENSOR ALERT OR SENSOR UPDATING ALERT NOTED. NO COMMUNICATION-BETWEEN PUMP & XMTR NOT CONFIRMED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND CRACKED RETAINER RING AT THE KNIT LINE LOCATION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT THE BATTERY CAP. ON THE PRIMARY SVN: (B)(6), UNABLE TO VERIFY CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED, DAILY TOTAL OF BASAL INSULIN DELIVERED AND DAILY TOTAL OF BOLUS INSULIN DELIVERED ON THE EVENT DATE 06-AUG-2025 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. ON THE PRIMARY SVN: (B)(6), PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 06-AUG-2025 IN THE PUMP HISTORY FILE AND FOUND 2 LOST SENSOR 1 ALERT (780) ON (B)(6) 2025, 2 SENSOR ERROR ALERT (801) ON (B)(6) 2025, 42 PUMP ERROR 130 ON (B)(6) 2025, 2 LOST SENSOR ALERTS ON (B)(6) 2025, 1 LOST SENSOR 1 ALERT (780) ON (B)(6) 2025, 9 PUMP ERROR 130 ON (B)(6) 2025, 1 PUMP ERROR 37 ON (B)(6) 2025 AND 2 LOST SENSOR 1 ALERT (780) ON (B)(6) 2025. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, LOST SENSOR ALERT OR SENSOR ERROR ALERT NOTED. PUMP ERROR 130 AND PUMP ERROR 37 WERE FOUND IN THE PUMP HISTORY FILE. THE PUMP HISTORY FILE LISTS DATA ON (B)(6) 2025. ON A RELATED SVN: (B)(6), UNABLE TO PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 24-FEB-2025 IN THE PUMP HISTORY FILE DUE TO NO DATA AVAILABLE. ON A RELATED SVN: (B)(6), PERFORM THE HISTORY REVIEW 2 DAYS PRIOR TO THE EVENT DATE 02-AUG-2025 IN THE PUMP HISTORY FILE AND FOUND 2 LOST SENSOR 1 ALERT (780) ON (B)(6) 2025, 2 SENSOR ERROR ALERT (801) ON (B)(6) 2025 AND 42 PUMP ERROR 130 ON (B)(6) 2025. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, LOST SENSOR ALERT OR SENSOR ERROR ALERT NOTED. PUMP ERROR 130 WAS FOUND IN THE PUMP HISTORY FILE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.1 MV). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS/HIGH BGS. NO COMMUNICATION-BETWEEN PUMP & XMTR NOT CONFIRMED. HOWEVER, PUMP ERROR 130 AND PUMP ERROR 37 WERE FOUND IN THE PUMP HISTORY FILE. ALARM-A339-PUMP ERROR 37 CONFIRMED, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AND THE MOTOR. ALARM-A370-PUMP ERROR 130 CONFIRMED, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AND THE MOTOR. DAMAGE-RETAINER RING DAMAGE CONFIRMED (DURING VISUAL INSPECTION FOUND CRACKED RETAINER RING AT THE KNIT LINE LOCATION). 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 HYPERGLYCEMIA AND HYPOGLYCEMIA. THE CUSTOMER ALSO REPORTED PUMP ERROR 37 (DRIVE COUNT/TIME VALUES OR CHANGES INCORRECT FOR MOVING OR COASTING. TOO SLOW OR TOO FAST). THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 57 MG/DL. THE CUSTOMER WAS TREATED FOR HYPERGLYCEMIA WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION) AND HYPOGLYCEMIA WITH GLUCOSE. THE EVENT INVOLVED PRODUCT(S) UNK_SENSOR, MMT-7841ZN, MMT-1884L, MMT-397A, MMT-332A. TROUBLESHOOTING WAS NOT PERFORMED FOR HYPOGLYCEMIA AND HYPOGLYCEMIA. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. TROUBLESHOOTING WAS PERFORMED FOR THE PUMP ERROR ALARM, AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE PUMP. TROUBLESHOOTING WAS PERFORMED FOR LOSS OF COMMUNICATION, AND THE CUSTOMER RECEIVED A LOST SENSOR ALARM. THE CUSTOMER REPORTED THAT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND ADVISED TO REVERT TO A BACKUP PLAN PER THE HEALTHCARE PROFESSIONAL'S INSTRUCTIONS AND PLACE THE PUMP IN STORAGE MODE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR UNK_SENSOR. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1884L WAS REQUESTED, AND THE CUSTOMER RESPONDED THAT THE DEVICE WOULD BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335083 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 NG3729893H 000076300081937801

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female