BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24362467 · Received February 17, 2026

    Report

    Report Number
    2032227-2026-128882
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    February 3, 2026
    Report Date
    April 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    SC1-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS NOT RECEIVED WITH ORIGINAL PACKAGING. AFTER BATTERY INSTALLATION UNIT GAVE A FLASHING MEDTRONIC LOGO. NO BLANK DISPLAY NOTED. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF-TEST DUE TO FLASHING MEDTRONIC LOGO. UNABLE TO TEST FOR ALARM/AUDIO ANOMALY DUE TO DISPLAY ANOMALY PREVENTING FURTHER TESTING. PROCEEDED BY CUTTING UNIT OPEN AND PERFORMING VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLY. DURING DECONSTRUCTIVE ANALYSIS, NO MOISTURE DAMAGE WAS NOTED ON ELECTRONIC STACK. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUMP SOFTWARE DUE TO DISPLAY ANOMALY. UNIT WAS ALSO RECEIVED WITH: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION, CUSTOMER'S ALLEGATIONS OF BLANK DISPLAY WERE NOT CONFIRMED WHEN UNIT POWERED ON WITH FLASHING MEDTRONIC LOGO. ALLEGATIONS OF OUT OF BOX DAMAGE WERE UNKNOWN AS UNIT WAS NOT RECEIVED WITH ORIGINAL PACKAGING. ALLEGATIONS OF ALARM/AUDIO ANOMALY UNKNOWN DUE TO DISPLAY ANOMALY PREVENTING FURTHER TESTING. HOWEVER, ALLEGATIONS OF FLASHING MEDTRONIC LOGO WERE CONFIRMED WHEN UNIT POWERED ON WITH FLASHING MEDTRONIC LOGO. ISOLATE TO ELECTRONIC ASSEMBLY. 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

    (B)(6) 2026 17:34:35 DOP114-980DOC_VER_BC: BEEP/VIBRATE ANOMALY/CONSTANT TONE CUSTOMER REPORTED AN AUDIO/VIBRATE ANOMALY. (B)(6) 2026 17:34:35 DOP114-980DOC_VER_BC: DISPLAY - FLASHING/WHITE/BLANK/FROZEN/PARTIAL CUSTOMER REPORTED AN ISSUE WITH THE PUMP DISPLAY. (B)(6) 2026 17:34:35 DOP114-980DOC_VER_BC: LABELING/PACKAGING "CUSTOMER REPORTED PRODUCT DAMAGED UPON RECEIPT, PRIOR TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549815 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 NG4293143H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male