BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24361861 · Received February 17, 2026

    Report

    Report Number
    2032227-2026-128641
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 26, 2026
    Report Date
    April 13, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO BLANK DISPLAY NOTED. UNIT PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS. PUMP DOWNLOADED HISTORY/TRACE FILE PROPERLY USING THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO UNEXPECTED BLANK DISPLAY NOTED DURING TESTING. HOWEVER, FOUND MULTIPLE FAILED BATT TEST ALARM ON 01/26/2026 22:12:12.000, 01/26/2026 22:21:08.000, 01/26/2026 22:28:20.000. IN TRACES/FILE HISTORY DUE TO BATTERY LOW. CUT AND OPEN THE PUMP FOUND MOISTURE DAMAGE ON THE ELECTRONIC, MOTOR, VIBRATOR DURING VISUAL INSPECTION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, LABEL DAMAGE. UNIT PASSED ALL TESTS REQUIRED. BLANK DISPLAY NOT CONFIRMED. HOWEVER, FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. CRACKED CASE (BATTERY TUBE) CONFIRMED. 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 REPORTED A CRACK ON BATTERY TUBE SIDE AND BLANK DISPLAY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR DISPLAY ISSUES. NO DAMAGE TO THE BATTERY CAP CONTACTS WAS REPORTED. DISPLAY DID NOT RETURN AFTER INSERTING A NEW AA BATTERY. INSTRUCTED CUSTOMER THAT PUMP WILL BE REPLACED. TROUBLESHOOTING WAS PERFORMED FOR COSMETIC DAMAGE ALLEGATION. CUSTOMER STATED THAT, DAMAGE AFFECTING/IMPACTING PUMP FUNCTIONALITY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE. MMT-1884 WAS REQUESTED, AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499723 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 NG3475543H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male