BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20061701 · Received August 26, 2024

    Report

    Report Number
    2032227-2024-225725
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 7, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 0.0869 INCHES. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADEDVOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. THE PUMP POWERED UP PROPERLY AFTER THE TEST BATTERY WAS INSERTED. THE PUMP WAS MONITORED FOR 2 DAYS. BLANK DISPLAY/PUMP SHUT DOWN ANOMALY WERE NOT CONFIRMED DURING TESTING. PUMP ERROR 43 NOT CONFIRMED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA1, PCBA2 AND MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, MISSING SERIAL NUMBER LABEL, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USINGTHUMP AND CARELINK UPLOAD WAS SUCCESSFUL. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 30-JUL-2024 IN THE PUMP HISTORY FILE. 07/25/2024 13:10:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORMOTIONALARM (37) 07/25/2024 13:12:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) 07/25/2024 13:12:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) 07/25/2024 13:22:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) 07/25/2024 13:23:00.000 BATTERYREMOVED (55) 07/25/2024 13:23:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 07/25/2024 13:23:20.000 BATTERYINSERTED (44) 07/27/2024 14:45:10.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: SENSORERRORALERT (801) 07/27/2024 15:19:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) 07/30/2024 21:33:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 8/3/2024 1:02:56 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 07/25/2024. UNABLE TO CHECK POWER DATA FOR FAILED BATT/BATTERY FAILED ALARM. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. 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 240 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, SENSOR ERROR ALERT, OR LOST SENSOR ALERT NOTED. THE PUMP PASSED THE FUNCTIONAL TESTING. THERE WERE NO PUMP ERROR 37 OR PUMP ERROR 43 NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA1, PCBA2 AND MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR. PUMP ERROR 37 AND PUMP ERROR 43 WERE FOUND WHEN REVIEW THE PUMP HISTORY FILE DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. PUMP ERROR 37 - CONFIRMED. FAILEDBATTTEST (58) - UNKNOWN. SENSOR ERROR ALERT - NOT CONFIRMED. LOST SENSOR ALERT - NOT CONFIRMED. PUMP ERROR 43 - CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. BLANK DISPLAY NOT CONFIRMED DURING TESTING. NO CURRENT CODE/CATEGORY NOT CONFIRMED DURING TESTING (PER CUSTOMER NOTES "PUMP SHUT DOWN TWICE FOR THE PAST WEEK").PUMP ERROR 43 CONFIRMED IN THE PUMP HISTORY FILE (FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR). PUMP ERROR 37 CONFIRMED IN THE PUMP HISTORY FILE (FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR). 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 PUMP ERROR 43 AND THE PUMP SHUT DOWN TWICE FOR THE PAST WEEK. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED IT WAS REPORTED CUSTOMER ABLE TO SUCCESSFULLY CLEAR ALARM AND WAS UNABLE TO COMPLETE THE REWIND. 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
    1481669 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 HG6DRSBZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male