BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24467918 · Received February 27, 2026

    Report

    Report Number
    2032227-2026-136183
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545604
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED DISPLACEMENT TEST AND SELF-TESTS. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUMP SOFTWARE. [ON ADAPT, IN FURTHER REVIEW FOUND PUMP ERROR 53 AND 54 ALARMS IN HISTORY FILE CONFIRMED (53) ALARM ON (B)(6) 2026 18:29:31.000 AND (54) (B)(6) 2026 18:24:39.000 ALARM ON HOUR FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING A COMPLAINT CALL THAT MIGHT HAVE TRIGGERED THE REASON COMPLAINT. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE INTERNAL LITHIUM BACKUP BATTERY CONNECTOR ON J6/PCBA 1. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, J6/PCBA 1. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, LABEL DAMAGED AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION, PUMP ERROR 53/54 FOUND WERE CONFIRMED DUE TO MOISTURE DAMAGE ON THE J6/PCBA 1 CONNECTOR. FOR ADDITIONAL INFORMATION REGARDING THE TESTS PERFORMED REFER TO (B)(4) ¿APPENDIX E. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 PUMP ERROR 53 (SOFTWARE ERROR DETECTED), PUMP ERROR 54 (HAL SOFTWARE ERROR DETECTED). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO REWIND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111225 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 NG3226653H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male