BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21455816 · Received February 25, 2025

    Report

    Report Number
    2032227-2025-128554
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 17, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. THE PUMP WAS MONITORED AND NO FLASHING MEDTRONIC LOGO NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 2 DAYS PRIOR TO THE EVENT DATE OF 31-JAN-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: 01/31/2025 07:45:19.000. 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. PUMP ERROR 4 ALARM WAS FOUND ON: 01/31/2025 07:42:01.000. PUMP ERROR 63 ALARM (FILE NUMBER: 632 2101 LINE NUMBER: 5590 249) WAS FOUND ON: 01/31/2025 07:42:01.000 PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (FILE NUMBER: 632 2101 LINE NUMBER: 5590 249) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. PUMP ERROR 68 ALARM WAS FOUND ON: 01/31/2025 07:42:03.000. PUMP ERROR 49 ALARM WAS FOUND ON: 01/31/2025 07:42:03.000, 01/31/2025 07:42:21.000. PUMP ERROR 23 ALARM WAS FOUND ON: 01/31/2025 07:42:33.000, 01/31/2025 07:45:31.000, POWER LOSS ALARM WAS FOUND ON: 01/31/2025 07:46:43.000, 01/31/2025 07:46:51.000. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESET/RESTARTED DUE TO PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM. NO UNEXPECTED PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. ALL BUTTONS FUNCTION PROPERLY. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1 AND PCBA 2. NO PHYSICAL OR MOISTURE DAMAGE ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE J1 CONNECTOR ON PCBA 1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (24.25 MV). TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR KEYPAD ANOMALY AND FLASHING MEDTRONIC LOGO WERE NOT CONFIRMED. HOWEVER, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (FILE NUMBER: 632 2101 LINE NUMBER: 5590 249) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION 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 INSULIN PUMP ALARMED WITH MEDTRONIC ON THE SCREEN AND THE DID NOT RESPOND. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR THE DISPLAY ISSUE AND FOUND THAT THE FLASHING MEDTRONIC LOGO ON THE SCREEN AND THE ISSUE WERE NOT RESOLVED. TROUBLESHOOTING WAS PERFORMED FOR THE KEYPAD ANOMALY AND THE PUMP WASN'T EXPOSED TO A CHANGE IN ALTITUDE BUT THERE WAS A MINUTE CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168907 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 HG4VGJ0ZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male