BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 24385024 · Received February 18, 2026

    Report

    Report Number
    2032227-2026-130500
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 21, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000586195
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO DAMAGE TO RETAINER RING DURING VISUAL INSPECTION NOTED. THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SELF-TEST AND DISPLACEMENT ACCURACY TEST. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES, AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN DAILY HISTORY. NO DATA ANOMALY NOTED DURING CARE LINK PRO DOWNLOAD. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. HOWEVER, PUMP ERROR 37 ALARM WAS NOTED AT LONG HISTORY FILE ON (B)(6) 2026 21:41:00:000 NO DAMAGE NOTED AT MOTOR DEVICE. THE 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. UNIT RECEIVED CRACKED BATTERY TUBE THREADS, FADING SERIAL NUMBER LABEL, AND CRACKED CASE AT BATTERY TUBE SIDE. IN SUMMARY, THE CUSTOMER ALLEGED POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. UNIT PASSED ALL REQUIRED TESTING. NO UNEXPECTED DRIVE MOTOR ANOMALIES NOTED. NO MAGNETIC FIELD OR MRI EXPOSURE NOTED. HOWEVER, PUMP ERROR 37 ALARM WAS NOTED AT LONG HISTORY FILE ON (B)(6) 2026 21:41:00:000 NO DAMAGE NOTED AT MOTOR DEVICE 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, PUMP ERROR 37 (DRIVE COUNT/TIME VALUES OR CHANGES INCORRECT FOR MOVING OR COASTING. TOO SLOW OR TOO FAST) ALARM, POSSIBLE OVER DELIVERY ANOMALY AND REPORTED INSULIN PUMP WAS EXPOSED TO STRONG MAGNETIC FIELD. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 45 MG/DL AND THE HYPOGLYCEMIC EVENT WAS TREATED WITH GLUCOSE/CARB INTAKE. THE EVENT INVOLVED PRODUCT(S) MMT-242A, MMT-1880L, MMT-332A. TROUBLESHOOTING WAS PERFORMED FOR HYPERGLYCEMIA. CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-242A WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. MMT-1880L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. MMT-332A WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56113 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3499522H 000000763000586195

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Other FRN-MMT-332A-RSVR, UNOMED SET.