BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 21671677 · Received March 22, 2025

    Report

    Report Number
    2032227-2025-140882
    Event Type
    Injury
    Date Received
    March 22, 2025
    Date of Event
    February 27, 2025
    Report Date
    June 19, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063922801
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.0876 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW AND SCRATCHED CASE. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT THE BATTERY CAP. ON THE EVENT DATE OF 27-FEB-2025 OF THE DAILY TOTAL COLLECTION START TIME, THE DAILY TOTAL OF BASAL INSULIN DELIVERED = 103250 (10.325 U) AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 100000 (10 U) WHICH IS EQUAL TO THE DAILY TOTAL OF ALL INSULIN DELIVERED = 203250 (20.325 U).PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 27-FEB-2025 IN THE PUMP HISTORY FILE AND FOUND LOST SENSOR 1 ALERT ON (B)(6) 2025, LOW BATTERY ALERT (104) ON (B)(6) 2025 13:19:00.000, CHANGE BATTERY FAULT (73) ON (B)(6) 2025 22:50:00.000 AND 3 NO DELIVERY (7) ON (B)(6) 2025 (DURING BASAL).THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 13.3 MMOL/L ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALERT NOTED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2025 7:50:57 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE/TIME OF (B)(6) 2025 AT 13:19:00.000. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. THE REPLACE BATTERY ALERT/CHANGE BATTERY FAULT (73) WAS EXPECTED (TRIGGERED 9.5 HOURS AFTER THE LOW BATTERY ALERT). THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED.FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.9 MV). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. DAMAGE-MOISTURE NOT 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 PUMP LEAKED INSULIN THAT LED TO HYPERGLYCEMIA. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 26.0 MMOL/L. THE CUSTOMER REPORTED HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS. THE CUSTOMER HAD AN EMERGENCY ROOM VISIT AND WAS HOSPITALIZED AND WAS TREATED BY AN IV INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED FOR HYPERGLYCEMIA AND MOISTURE DAMAGE. THE EVENT INVOLVED PRODUCT(S) MMT-1885. THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. THE PUMP WAS NOT IN USE WHEN BEING HOSPITALIZED. THE CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. THE CUSTOMER REPORTED THAT THE PUMP WAS EXPOSED TO MOISTURE AS THE INSULIN WAS PRESENT AND FLUID WAS PRESENT IN THE RESERVOIR COMPARTMENT. NO DAMAGE WAS REPORTED TO THE RESERVOIR COMPARTMENT OR PUMP CASE. THE PUMP PASSED THE SELF-TEST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1885 WILL BE RETURNING FOR ANALYSIS AND THE PUMP WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129049 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3520965H 000076300063922801

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown