BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 22083558 · Received May 26, 2025

    Report

    Report Number
    2032227-2025-181041
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    April 29, 2025
    Report Date
    August 4, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS, A CRACKED CASE BEHIND THE PUMP AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED, NO PUMP ERROR 25 ALARM, UNEXPECTED BATTERY POWER LOSS AND CHARGE/BATTERY LASTS LESS THAN EXPECTED NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED PUMP ERROR 25, REPLACE BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM. INSERT BATTERY ALARM WAS FOUND ON: 04/24/2025 05:08:12.000, 04/24/2025 21:01:03.000 04/25/2025 09:10:23.000 04/26/2025 17:02:03.000 04/27/2025 20:00:35.000, 04/27/2025 23:02:00.000 04/29/2025 14:01:09.000, 04/29/2025 14:01:33.000, 04/29/2025 14:01:50.000 REPLACE BATTERY ALERT WAS FOUND ON: 04/24/2025 05:00:00.000, 04/24/2025 21:00:00.000 04/25/2025 09:00:00.000 04/26/2025 17:00:00.000 04/27/2025 20:00:00.000, 04/27/2025 23:00:00.000 04/29/2025 14:00:00.000 PUMP ERROR 25 ALARM WAS FOUND ON: 04/25/2025 00:00:00.000 04/25/2025 04:01:06.000 04/25/2025 12:00:00.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 04/29/2025 14:01:27.000 04/29/2025 14:01:40.000 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 28-APR-2025 AT 06:17:58.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 24-APR-2025, 25-APR-2025, 26-APR-2025, 27-APR-2025 AND EVENT DATE OF 29-APR-2025. UNABLE TO CHECK POWER DATA FOR REPLACE BATTERY ALERT, PUMP ERROR 25 ALARM AND FAILED BATTERY ALERT/BATTERY FAILED ALARM. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE: BATTERY CYCLE 1 RECEIVED THE LOWBATTERYALERT (104) ON 03/28/2025 08:55:01 FASTER THAN EXPECTED AT 6.54 DAYS. BATTERY CYCLE 2 RECEIVED THE LOWBATTERYALERT (104) ON 03/13/2025 18:10:00 FASTER THAN EXPECTED AT 3.29 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. POWER MANAGEMENT TOOL CONFIRMED PUMP ERROR 25 ALARM, UNEXPECTED BATTERY POWER LOSS, CHARGE/BATTERY LASTS LESS THAN EXPECTED, REPLACE BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE TRIGGERED WHEN THE BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE TO CONNECTOR RESISTANCE J6/PCB1. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6/PCB 1, THE PUMP WAS MONITORED AND FUNCTIONED PROPERLY. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 29-APR-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: SENSOREXPIREDALERT (794) WAS FOUND ON: 04/23/2025 15:36:11.000 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 EXPIRED ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A KEYPAD OVERLAY PEELING, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. COSMETIC DAMAGE WAS CONFIRMED AT THE CASE - BATTERY TUBE SIDE OF THE PUMP DURING ANALYSIS. PUMP ERROR 25 ALARM, UNEXPECTED BATTERY POWER LOSS, CHARGE/BATTERY LASTS LESS THAN EXPECTED, REPLACE BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE CONFIRMED DUE TO CONNECTOR RESISTANCE J6/PCB1. DURING VISUAL INSPECTION, SLIGHT CORROSION WAS FOUND ON THE PCBA 1 AND PCBA 2. 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 A PUMP ERROR 23(POST-RESET RAM CRC ALARM), BATTERY DEPLETED VERY QUICKLY, LASTING ONLY TWO DAYS, AND A POWER ERROR WAS DETECTED. ADDITIONALLY, THERE WAS A CRACK ON THE PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE THE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729357 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 HG596QMZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female