BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24386055 · Received February 19, 2026

    Report

    Report Number
    2032227-2026-130857
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000924089
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP ERROR LOG FILE AND HISTORY FILE USING THUMP. UNABLE TO DOWNLOAD PUMP TRACES FILE USING THUMP AND UPLOAD PUMP TO CARELINK DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. AS PER R&D ENGINEER MARK FREGER: BASED ON THE ERROR LOGS, THE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS GENERATED DUE TO 3 SEQUENTIAL PUMP ERROR 53 (FILENUM/LINENUM=174/334) THAT WERE TRIGGERED IN THE UHP_FILTER.C FUNCTION UHP_FILTERSGDAILYHISTOR() LINE 334: CHECK_SG_DAILY_HISTORY_BOUNDS(PHISTORY->ITEMS[PHISTORY->COUNT - 1]) - THIS IS THE SW ISSUE. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK FROM THE EVENT DATE OF 01-FEB-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: 01/26/2026 00:19:00.000 TO 01/26/2026 11:54:00.000. 01/28/2026 13:15:00.000.. 01/29/2026 23:27:00.000. 01/30/2026 01:30:00.000 TO 01/30/2026 22:42:00.000. 01/31/2026 05:54:00.000 TO 01/31/2026 15:25:00.000. 02/01/2026 15:46:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 01/31/2026 14:53:00.000. 01/31/2026 15:41:00.000. SGCALIBRATIONERROR (776) WAS FOUND ON: 01/31/2026 20:13:35.000. INSERT BATTERY ALARM WAS FOUND ON: 01/30/2026 18:41:05.000. 01/30/2026 18:41:33.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 01/30/2026 18:42:00.000. UNABLE TO GENERATE POWER MANAGEMENT GRAPH DUE TO MISSING PUMP TRACES FILE. UNABLE TO VERIFY/TEST FOR LOST SENSOR ALERT, SG CALIBRATION ERROR AND FAILED BATTERY ALERT/BATTERY FAILED ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT, SG CALIBRATION ERROR AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE UNKNOWN. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.32 MV). THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, (B)(4). THE TEST SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. UNABLE TO PERFORM THE REQUIRED TESTING, DOWNLOAD PUMP TRACES USING THUMP AND UPLOAD PUMP TO CARELINK DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO THREE CONSECUTIVE PUMP ERROR 53 ALARMS. PUMP ERROR 53 ALARM (FILENUM/LINENUM=174/334) DUE TO SOFTWARE ISSUE. 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 CRITICAL PUMP ERROR. IT WAS ALSO MENTIONED THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE FOR MORE THAN 4 HOURS AND WAS TREATED WITH AN EMERGENCY ROOM VISIT. TROUBLESHOOTING WAS PERFORMED, EXPLAINED THE PUMP PERFORMS SAFETY CHECKS AND AN ERROR WAS FOUND. THE EVENT INVOLVED PRODUCT(S) MMT-1884L, MMT-332A, MMT-399AMMT-399A AND MMT-6102. IT WAS MENTIONED THAT THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS BEFORE THE EVENT AND MENTIONED THE AUTO MODE FEATURE WAS NOT ACTIVE. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218299 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 NG3957391H 000000763000924089

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention FRN-UNK-RSVR, UNOMED INF SET