BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24579568 · Received March 12, 2026

    Report

    Report Number
    2032227-2026-143318
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). UPON BATTERY INSTALLATION NO UNEXPECTED FAIL BATT ALERTS NOTED. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAINT CALLS THAT MIGHT OF TRIGGER THE REASON COMPLAINT. UNIT PASSED THE DISPLACEMENT TEST AND SELF TEST. DURING DOWNLOAD REVIEW ON 02/25/2026 PUMP ERROR 15 AND 23 WERE RECORDED. PER R&D INVESTIGATION, LINE NUMBER=442 FILE NUMBER=38 WAS DUE TO A CORRUPTED DATA/INVALID POINTER. FAIL BATTERY TEST WAS RECORDED BY ADAPT ON 02/12/2026 21:51:23.000 THROUGH 02/12/2026 21:58:37.000. UNIT WAS CUT OPEN AND PERFORMED A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION ALL CONNECTORS INCLUDING MOTOR FLEX CONNECTOR WERE PLUGGED IN PROPERLY. NO MOISTURE DAMAGE NOTED DURING VISUAL INSPECTION. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. THE FOLLOWING COSMETIC DAMAGES WERE NOTED: CRACKED LCD WINDOW, SCRATCHED CASE, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY IN CONCLUSION, PUMP ERROR 15 WAS CONFIRMED USING DOWNLOAD HISTORY FILES DUE TO CORRUPTED DATA/INVALID POINTERS. NO UNEXPECTED PUMP ERROR 23 ALARMS NOTED. NO FAIL BATTERY TEST ALARMS NOTED DURING TESTING. 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 PUMP ERROR 15 (THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO), PUMP ERROR 23 (POST-RESET RAM CRC ALARM), BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO REWIND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 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
    171263 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG3820933H

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female