BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21771084 · Received April 4, 2025

    Report

    Report Number
    2032227-2025-148455
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 19, 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
    WI, 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 .08675 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE PRIMARY SVN#: (B)(6) EVENT DATE OF 07-MAR-2025 AND RELATED SVN#: (B)(6) EVENT DATE OF 25-FEB-2025, THERE WERE 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 PRIMARY SVN#: (B)(6) EVENT DATE OF 07-MAR-2025 AND RELATED SVN#: (B)(6) EVENT DATE OF 25-FEB-2025, LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE PRIMARY SVN#: 000319308161 EVENT DATE OF 07-MAR-2025 AND RELATED SVN#: (B)(6) EVENT DATE OF 25-FEB-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: SENSORERRORALERT (801) WAS FOUND ON: 02/21/2025 07:14:15.000, 02/21/2025 07:24:00.000; 03/03/2025 17:38:05.000, 03/03/2025 19:38:06.000; 03/03/2025 21:43:04.000, 03/03/2025 21:53:00.000, 03/03/2025 23:43:05.000; 03/04/2025 01:43:06.000; 03/07/2025 08:24:08.000. LOSTSENSOR1ALERT (780) WAS FOUND ON: 02/20/2025 04:04:00.000; 02/21/2025 09:05:00.000, 02/21/2025 09:15:00.000; 02/24/2025 21:39:00.000; 03/05/2025 00:36:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 02/20/2025 04:20:00.000, 02/20/2025 04:30:00.000; 02/24/2025 21:55:00.000; 03/05/2025 00:52:00.000. SENSORSIGNALNOTFOUND (796) WAS FOUND ON: 02/20/2025 05:33:00.000; 02/20/2025 05:43:00.000. 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 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR ERROR ALERT, LOST SENSOR ALERT, SENSOR SIGNAL NOT FOUND OR UNEXPECTED SENSOR/TRANSMITTER ERRORS OR ANOMALIES WERE NOTED DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: 02/21/2025 07:06:00.000. INSERT BATTERY ALARM WAS FOUND ON: 02/21/2025 07:47:03.000. 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 05-MAR-2025 AT 04:23:59.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 21-FEB-2025. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. NO UNEXPECTED LOW BATTERY ALERT 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 (22.93MV). THE PUMP WAS RECEIVED WITH A DEPLETED ENERGIZER MAX ALKALINE BATTERY INSTALLED. 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 SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. CUSTOMER ALLEGED FOR PUMP/TRANSMITTER/SENSOR COMMUNICATION ANOMALY WAS 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. THIS IS 2 OF 3 MEDWATCH REPORTS REGARDING THIS EVENT. 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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND RECEIVED "SENSOR UPDATING" FOR 4HRS, "CHANGE SENSOR" AND "SENSOR NOT FOUND". THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 700 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS AND WAS HOSPITALIZED AND TREATED WITH AN IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-342, MMT-1884, MMT-431AH, MMT-7841ZN. TROUBLESHOOTING WAS PERFORMED AND THE AUTO MODE/SMARTGUARD FEATURE WAS NOT APPLICABLE. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER WAS UNABLE TO RUN A TRANSMITTER TEST OR TEST PASSED. THE CUSTOMER ALSO REPORTED A LOSS OF COMMUNICATION BETWEEN THE TRANSMITTER AND THE PUMP. THE CUSTOMER REPORTED SYMPTOMS OF TIREDNESS/WEAKNESS AT THE TIME OF THE HOSPITALIZATION EVENT. THE SENSOR GLUCOSE (SG) VALUE FROM THE REPORTED HOSPITALIZATION EVENT WAS 400 MG/DL AND THE BLOOD GLUCOSE (BG) VALUE WAS 700 MG/DL AND THE DIFFERENCE WAS NOT WITHIN THE TARGET RANGE AND WAS MORE THAN 30%. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A BUT THE CUSTOMER WAS INFORMED THAT THE SENSOR WILL BE REPLACED. NO PRODUCT RETURN IS REQUIRED FOR MMT-342. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-431AH. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325300 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 NG3772088H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| O FRN-MMT-342-RSVR, UNOMED INF SET.