BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19190287 · Received April 26, 2024

    Report

    Report Number
    2032227-2024-159894
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 28, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF-TEST. NO LOW BATTERY ALARM NOTED DURING TESTING. THE PUMP WAS MONITORED FOR SEVERAL HOURS, AND NO PUMP ERROR 25 ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED PUMP ERROR 25. DETAIL TRACE ANALYSIS CONFIRMED THE PUMP ALARMED LOW BATTERY AND THEN ALARMED PUMP ERROR 25 WAS TRIGGERED WHEN BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE TO CONNECTOR RESISTANCE (J6 PCB 1). AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR AT J6 PCBA 1. PUMP WAS MONITORED AND FUNCTIONED PROPERLY. NM_CHANGE_BATTERY_E (73) 03/29/2024 21:00:00.000. NM_BATTERY_REMOVED_E (84) 03/29/2024 21:08:36.000. NM_LOST_SENSOR1_E (780) 04/03/2024 19:16:00.000. NM_CHANGE_BATTERY_E (73) 04/05/2024 16:00:00.000. NM_OFF_NO_POWER_E (11 )04/05/2024 16:31:00.000. NM_BATT_OUT_LIMIT_E (6) 04/05/2024 16:43:03.000. NM_CHANGE_BATTERY_E (73) 04/05/2024 20:00:00.000. NM_BATTERY_REMOVED_E (84) 04/05/2024 20:03:20.000. NM_CHANGE_BATTERY_E (73) 04/05/2024 22:00:00.000. NM_OFF_NO_POWER_E (11) 04/05/2024 22:31:00.000. NM_BATT_OUT_LIMIT_E (6) 04/05/2024 22:42:20.000. NM_BATTERY_REMOVED_E (84) 04/05/2024 22:56:22.000 TO 04/05/2024 23:24:34.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, BATTERY TUBE THREADS - CRACKED AND CRACKED CASE-CORNER OF BELT CLIP RAILS. PASSED ALL REQUIRED TESTING. LOW BATTERY ALARM CONFIRMED. PUMP ERROR 25 ALARM WAS CONFIRMED. PUMP ERROR 25 ALARM DUE TO CONNECTOR RESISTANCE ISSUE ON J6/PCB1. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 DAMAGE (PHYSICAL OR COSMETIC), UNEXPECTED BATTERY POWER LOSS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. CUSTOMER REPORTED RECEIVING A POWER LOSS ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE DEVICE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982955 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 HG50FJ0ZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female