BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24565102 · Received March 10, 2026

    Report

    Report Number
    2032227-2026-142121
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP ALARMED CRITICAL PUMP ERROR AFTER BATTERY INSTALLATION. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. THE PUMP HISTORY DOWNLOAD CONFIRMED THE PUMP ALARMED 3 CONSECUTIVE PUMP ERROR 53 ALARMS (LINE NUMBER 396 FILE NUMBER 174) ON 03/03/2026 18:30:08 AND 03/03/2026 18:30:23.000 DUE TO SW ISSUE AS PER GLOBAL LOGIC ANALYSIS. UNABLE TO PERFORM SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT TEST DUE TO CRITICAL PUMP ERROR. FOUND MOISTURE PCB1 BOARD AND PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, CRACKED BATTERY TUBE THREADS, AND CRACKED KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. UNABLE TO PERFORM THE REQUIRED TESTING DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DURING ANALYSIS AND TRIGGERED BY 3 CONSECUTIVE PUMP ERROR 53 ALARMS. PUMP ERROR 53 ALARMS (LINE NUMBER 396 FILE NUMBER 174) DUE TO SOFTWARE ANOMALY. DURING VISUAL INSPECTION, FOUND MOISTURE ON THE PCB1 BOARD AND PCB2 BOARD. 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 HYPERGLYCEMIA. THE CUSTOMER REPORTED PUMP ERROR 53 (SOFTWARE ERROR DETECTED) AND OPEN BOOK IMAGE. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF EVENT. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1884, UNOMEDICAL, UNK_RESERVOIR, MMT-6102. TROUBLESHOOTING WAS PERFORMED FOR THE PUMP ERROR. TROUBLESHOOTING WAS NOT PERFORMED FOR THE HARM. IT WAS UNKNOWN THAT THE CUSTOMER WAS USING THE PUMP FOR 48 HOUR BEFORE THE REPORTED EVENT AND UNKNOWN THAT THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT.. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL, UNK_RESERVOIR. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE. PRODUCT RETURN IS NOT APPLICABLE FOR NON PHYSICAL DEVICES MMT-6102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625812 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 NG3240400H

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male