BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 23568367 · Received November 17, 2025

    Report

    Report Number
    2032227-2025-301696
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 18, 2025
    Report Date
    January 21, 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
    WI, 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 SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT WITHIN SPECIFICATION AT .08730 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. ON THE EVENT DATE OF 18-OCT-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 EVENT DATE 18-OCT-2025 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 2 DAYS PRIOR TO THE EVENT DATE OF 18-OCT-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: 10/18/2025 08:19:00.000. 10/18/2025 08:29:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 10/18/2025 08:47:00.000. 10/18/2025 08:57:00.000. 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 LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. 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 SCRATCHED CASE AND A SERIAL NUMBER LABEL MISSING. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS. COSMETIC DAMAGE WAS CONFIRMED AT THE CASE - BATTERY COMPARTMENT OF THE PUMP DURING ANALYSIS. DURING VISUAL INSPECTION, CORROSION WAS FOUND ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 48 MG/DL AND WAS TREATED WITH GLUCOSE TABLETS. THE EVENT INVOLVED PRODUCT(S) UNKNOWN SENSOR, UNOMEDICAL, MMT-332A, MMT-1884L. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. IT WAS ALSO CONFIRMED THAT THE CUSTOMER OBSERVED CRACK AT BATTERY TUBE SIDE OF THE INSULIN PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PRODUCTS UNKNOWN SENSOR, UNOMEDICAL, MMT-332A WILL NOT BE RETURNED FOR ANALYSIS. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PRODUCT MMT-1884L WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858176 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 HG6FZ8S

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other FRN-MMT-332A-RSVR, UNOMED SET, MDS-UNKNOWN SENSOR-SNSR