BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 18640757 · Received February 5, 2024

    Report

    Report Number
    2032227-2024-120367
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 16, 2024
    Report Date
    March 1, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF TEST. NO BLANK DISPLAY NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. DURING VISUAL INSPECTION, THE PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, MISSING SERIAL NUMBER LABEL, KEYPAD OVERLAY TEXTURE DAMAGE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND STAINED KEYPAD OVERLAY. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 16-JAN-2024 IN THE PUMP HISTORY FILE. 01/11/2024 01:38:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERYAFTERESTIMATEZERO (8) - DURING BOLUS. 01/11/2024 01:48:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERYAFTERESTIMATEZERO (8) - DURING BOLUS. 01/12/2024 09:07:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: SENSORERRORALERT (801) 01/12/2024 10:37:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: SENSORERRORALERT (801) 01/12/2024 10:47:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: SENSORERRORALERT (801) 01/12/2024 23:54:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) 01/13/2024 09:25:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: CHANGEBATTERYFAULT (73) 01/13/2024 09:32:43.000 BATTERYREMOVED (55) 01/13/2024 09:32:43.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 01/13/2024 09:32:57.000 BATTERYINSERTED (44) 01/14/2024 14:32:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERYAFTERESTIMATEZERO (8) - DURING BOLUS. 01/14/2024 14:42:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERYAFTERESTIMATEZERO (8) - DURING BOLUS. 01/16/2024 06:22:14.000 BATTERYREMOVED (55) 01/16/2024 06:22:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 01/16/2024 06:32:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 01/16/2024 06:33:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) 01/16/2024 06:34:03.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) 01/16/2024 06:34:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) 01/16/2024 06:35:14.000 BATTERYREMOVED (55) 01/16/2024 06:35:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 01/16/2024 06:45:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 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. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. 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 ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR SENSOR ERROR ALERT NOTED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 1/14/2024 AT 9:45:59 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF 01/12/2024 TO 01/13/2024. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND REPLACE BATTERY ALERT/CHANGEBATTERYFAULT (73). PUMP ERROR 23 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES AND THE PUMP RESET. NODELIVERY NOT CONFIRMED. SENSORERRORALERT NOT CONFIRMED. LOWBATTERYALERT (104) UNKNOWN. CHANGEBATTERYFAULT (73) UNKNOWN. PUMP ERROR 23 NOT CONFIRMED. BATTOUTLIMIT (6) NOT CONFIRMED. BLANK DISPLAY WAS NOT OBSERVED DURING ANALYSIS AND PASSED ALL REQUIRED TESTING. BLANK DISPLAY NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE FRONT OF THE PUMP AND AT THE BACK OF THE PUMP. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A BLANK DISPLAY ON THE INSULIN PUMP AND ALSO THE HAD RUBBED OFF ON THE BACK OF THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE DISPLAY REMAINED BLANK EVEN AFTER REPLACING NEW AA BATTERIES AND RESTARTING THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287804 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 HG50JJVZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male