BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 23814135 · Received December 16, 2025

    Report

    Report Number
    2032227-2025-322688
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    August 18, 2025
    Report Date
    January 22, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 .08735 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 09/28/2025 TO 11/24/2025. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND DAILY TOTAL OF BASAL/BOLUS DELIVERY FOR THE SS EVENT DATE OF 18-AUG-2025 AND SAP NOTE/CUSTOMER'S EVENT DATE OF 20-AUG-2025. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERROR(S)/ALARM(S) 1 WEEK PRIOR TO THE SS EVENT DATE OF 18-AUG-2025 AND SAP NOTE/CUSTOMER'S EVENT DATE OF 20-AUG-2025 IN THE FORMATTED HISTORY FILE. ON THE (2ND HOSPITALIZATION) EVENT DATE OF 17-NOV-2025, THERE IS 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 (2ND HOSPITALIZATION) EVENT DATE 17-NOV-2025 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 (2ND HOSPITALIZATION) EVENT DATE OF 17-NOV-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: SENSOR EXPIRED ALERT (794) WAS FOUND ON: 11/11/2025 19:01:11.000 LOSTSENSOR1ALERT (780) WAS FOUND ON: 11/16/2025 04:00:00.000. 11/16/2025 04:10:00.000. 11/16/2025 22:54:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 11/16/2025 07:19:00.000. 11/16/2025 07:29:00.000. 11/16/2025 23:10:00.000. SENSORSIGNALNOTFOUND (796) WAS FOUND ON: 11/16/2025 09:41:00.000. 11/16/2025 23:53:00.000. 11/17/2025 00:03:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR EXPIRED ALERT, LOST SENSOR ALERT, SENSOR SIGNAL NOT FOUND OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE 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 (23.02 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITH A BATTERY CAP WITH A BROKEN 1 HEAT STAKE POST. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA/LOW 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 CUSTOMER EXPERIENCED HYPOGLYCEMIA, HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS. THE CUSTOMER ALSO ALLEGED FOR A HAIRLINE CRACK ON THE BACKSIDE OF THE PUMP, ON THE BATTERY TUBE, ANGLED CRACK. THE REPORTED HYPOGLYCEMIA WAS TREATED BY TAKING CUSTOMER TO EMERGENCY ROOM VISIT VIA AMBULANCE, HOSPITALIZATION, EMERGENCY MEDICAL SERVICE DISPATCHED. THE REPORTED HYPERGLYCEMIA WAS TREATED BY TAKING CUSTOMER TO EMERGENCY ROOM VISIT VIA AMBULANCE, HOSPITALIZATION, EMERGENCY MEDICAL SERVICE DISPATCHED AND IV INSULIN DRIP. SYMPTOMS WITNESSED AT THE TIME OF ADMISSION: UNCONSCIOUS. THE EVENT INVOLVED PRODUCTS MMT-1884L, MMT-7040MA, MMT-874A AND MMT-332A. TROUBLESHOOTING WAS PARTIALLY PERFORMED FOR LOW BLOOD GLUCOSE. THE CUSTOMER HAS USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER USED THE SMARTGUARD/AUTO MODE OF THE INSULIN PUMP AT THE TIME OF REPORTED EVENT. TROUBLESHOOTING WAS PERFORMED FOR COSMETIC DAMAGE AND INDICATED THAT THE PUMP WOULD BE REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. MMT-1884L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040MA. NO PRODUCT RETURN IS REQUIRED FOR MMT-874A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281568 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 NG3625904H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| H FRN-MMT-332A-RSVR, UNOMED INF SET| OZP-MMT-7040MA-SNSR