BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 24361459 · Received February 17, 2026

    Report

    Report Number
    2032227-2026-128502
    Event Type
    Death
    Date Received
    February 17, 2026
    Date of Event
    January 28, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300081938501
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED 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, DISPLACEMENT TEST AND DAT WITHIN SPECIFICATION AT .08720 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2025 TO (B)(6) 2026 ON (B)(6) 2026 08:38:08.000 USERTIMEDATECHANGE (3) SYSTEMTIME = (B)(6) 2026 08:38:08.000 NEWSYSTEMTIME: (B)(6) 2024 08:37:07.000 THEN FROM (B)(6) 2024 TO (B)(6) 2024 ON (B)(6) 2024 15:27:16.000 USERTIMEDATECHANGE (3) SYSTEMTIME = (B)(6) 2024 15:27:16.000 NEWSYSTEMTIME: (B)(6) 2025 16:12:15.000 THEN FROM (B)(6) 2025 TO (B)(6) 2025. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND DAILY TOTAL OF BASAL/BOLUS DELIVERY FOR THE PRIMARY SVN#: (B)(4) WITH EVENT DATE OF 28-JAN-2026, RELATED SVN#: (B)(4) WITH SS EVENT DATE OF 25-JAN-2026 AND RELATED SVN#: (B)(4) WITH SAP/CUSTOMER'S NOTE WITH EVENT DATE OF 23-JAN-2026. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERROR(S)/ALARM(S) 1 WEEK PRIOR TO THE PRIMARY SVN#: (B)(4) WITH EVENT DATE OF 28-JAN-2026, RELATED SVN#: (B)(4) WITH SS EVENT DATE OF 25-JAN-2026 AND RELATED SVN#: (B)(4) WITH SAP/CUSTOMER'S NOTE WITH EVENT DATE OF 23-JAN-2026 IN THE FORMATTED HISTORY FILE. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (4) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. NO UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. ON (B)(6) 2024, THERE WAS A SUCCESSFUL SOFTWARE UPDATE NOTED AS PER THE FORMATTED HISTORY FILE. SOFTWARE UPDATE WAS FROM OLDCODEVERSION: 6.21E TO NEWCODEVERSION: 6.61E. UNABLE TO PAIR THE BLE PUMP TO OUR CURRENT TEST ACCU-CHEK GUIDE LINK BG METER DUE TO SOFTWARE UPDATE. UNABLE TO CONFIRM PUMP/BG METER COMMUNICATION (BG METER READING) DUE TO SOFTWARE UPDATE. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.20 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITH A BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT AND A SLIGHTLY BROKEN/CHIPPED BELT CLIP RAILS. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS/HIGH BGS AND SENSOR GLUCOSE/BLOOD GLUCOSE (SG/BG) ANOMALY. 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. 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 PASSED AWAY. THE CAUSE OF DEATH WAS A HEART ATTACK AND HEART FAILURE. THE CUSTOMER ALSO EXPERIENCED THE HYPERGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF 400 MG/DL AND VISITED THE EMERGENCY ROOM. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: MMT-332A, MMT-397A, MMT-1884L. TROUBLESHOOTING WAS PERFORMED FOR DECEASED REPORTING. THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF THE REPORTED EVENT. THE PRODUCT RETURN IS REQUIRED FOR MMT-332A. THE PRODUCT RETURN IS REQUIRED FOR MMT-397A. PRODUCT RETURN REQUESTED FOR MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426290 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 NG3876166H 000076300081938501

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death| R FRN-MMT-332A-RSVR, OZP-MMT-7040A-SNSR, UNOMED SET.