BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 24398903 · Received February 20, 2026

    Report

    Report Number
    2032227-2026-131536
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 30, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300081937801
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. 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 .08745 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE PRIMARY SVN#: (B)(6) WITH EVENT DATE OF 04-FEB-2026, RELATED SVN#: (B)(6) WITH EVENT DATE OF 02-FEB-2026 AND RELATED SVN#: (B)(6) WITH EVENT DATE OF 03-FEB-2026, THERE WERE NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE PRIMARY SVN#: (B)(6) WITH EVENT DATE OF 04-FEB-2026, RELATED SVN#: (B)(6) WITH EVENT DATE OF 02-FEB-2026 AND RELATED SVN#: (B)(6) WITH EVENT DATE OF 03-FEB-2026 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE PRIMARY SVN#: (B)(6) WITH EVENT DATE OF 04-FEB-2026, RELATED SVN#: (B)(6) WITH EVENT DATE OF 02-FEB-2026 AND RELATED SVN#: (B)(6) WITH EVENT DATE OF 03-FEB-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: 01/30/2026 21:09:06.000. LOW BATTERY ALERT WAS FOUND ON: 01/30/2026 11:31:00.000. 02/04/2026 21:12:00.000. REPLACE BATTERY ALERT WAS FOUND ON: 01/30/2026 21:02:00.000. 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 EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 02-FEB-2026 AT 08:12:00.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 30-JAN-2026. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND REPLACE BATTERY ALERT. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT AT 02/04/2026 21:12:00.000 WAS EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER HAD USED A LOW POWER BATTERY. NO UNEXPECTED LOW BATTERY ALERT AND REPLACE BATTERY ALERT NOTED DURING TESTING. 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 (23.42 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 CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. COSMETIC DAMAGE WAS CONFIRMED AT THE CASE- BATTERY COMPARTMENT OF THE PUMP DURING ANALYSIS. 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 PATIENT EXPERIENCED A HIGH BLOOD GLUCOSE (BG) EVENT, WITH A PEAK BG OF 368 MG/DL AND WHICH HAS PERSISTED FOR MORE THAN FOUR HOURS. THE EVENT INVOLVED PRODUCT(S) MMT-332A,MMT-1884L,UNOMEDICAL. THE CUSTOMER HAS TYPE 1 DIABETES AND TREATED THE HIGH BG USING BOTH THE INSULIN PUMP AND NOVOLOG. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS NOT USING THE MINIMED 670G/770G/780G SYSTEM'S AUTO MODE/SMARTGUARD FEATURE AT THE TIME. THE CUSTOMER ALSO REPORTED A CRACK AT THE BACK OF THE BATTERY TUBE SIDE OF THE PUMP, BUT IT IS NOT CURRENTLY IMPACTING PUMP FUNCTIONALITY. THE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. THE PUMP, DISCONTINUE USE, AND REVERT TO THEIR BACKUP PLAN AS PER THEIR HEALTHCARE PROVIDER¿S INSTRUCTIONS. INSTRUCTIONS WERE PROVIDED ON HOW TO PUT THE PUMP IN STORAGE MODE AFTER DISCONTINUATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-332A,UNOMEDICAL WERE NOT EXPETED TO RETURN. MMT-1884L WAS EXPECTED TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461892 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 NG3763720H 000076300081937801

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET.