BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21737754 · Received April 1, 2025

    Report

    Report Number
    2032227-2025-146233
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 15, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED 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 WITHIN SPECIFICATION AT .08750 INCHES. 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. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE EVENT DATE OF 03-MAR-2025, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 03-MAR-2025 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. THE PUMP SUCCESSFULLY DELIVERED A 10 UNITS BOLUS DURING THE DISPLACEMENT TEST AND A 25 UNITS BOLUS DURING THE DAT. ALL BOLUSES WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 03-MAR-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: MULTIPLE NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON 25-FEB-2025, 26-FEB-2025, 27-FEB-2025 AND 01-MAR-2025 DURING BOLUS/BASAL DELIVERIES. LOSTSENSOR1ALERT (780) WAS FOUND ON: 03/02/2025 08:40:00.000; 03/03/2025 10:41:00.000. SENSORERRORALERT (801) WAS FOUND ON: 03/01/2025 14:40:50.000 TO 03/01/2025 23:00:00.000; 03/02/2025 02:50:51.000 TO 03/02/2025 22:28:00.000; 03/03/2025 00:18:50.000 TO 03/03/2025 08:38:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: 03/01/2025 08:34:00.000. INSERT BATTERY ALARM WAS FOUND ON: 03/01/2025 08:35:50.000; 03/03/2025 10:46:25.000; 03/03/2025 10:56:00.000. PUMP ERROR 23 ALARM WAS FOUND ON: 03/03/2025 10:57:04.000. POWER LOSS ALARM WAS FOUND ON: 03/03/2025 10:57:18.000; 03/03/2025 10:57:26.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 01-MAR-2025 AT 12:19:56.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 01-MAR-2025 AT 08:34:00.000. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED LOW BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. 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 (23.40 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITH A BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A STAINED KEYPAD OVERLAY, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY ANOMALY/BOLUS DELIVERY ANOMALY (PUMP IS NOT DELIVERING) AND NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE 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. 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 HIGH BLOOD GLUCOSE EVENT DUE TO THE PUMP WAS NOT DELIVERING INSULIN. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 1600 MG/DL AND WAS RUSHED TO INTENSIVE CARE UNIT IN THE HOSPITAL AND STAY FOR LESS THAN 24 HOURS AND DURING THE STAY CUSTOMER EXPERIENCED THROWING UP, NAUSEA, FEELING UNWELL AND HEADACHE. CUSTOMER ALSO HAD POSITIVE IN KETONE TEST RESULT. THE EVENT INVOLVED PRODUCT(S) MMT-1884, MMT-332A, MMT-397A, MMT-7040A. CUSTOMER DECLINED THE TROUBLESHOOTING. IT WAS UNKNOWN WHETHER THE CUSTOMER USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT OR NOT. IT WAS UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT OR NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171056 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 NG3222310H

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention FRN-MMT-332A-RSVR,UNOMED INF SET| OZP-MMT-7040A- SNSR