BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21700956 · Received March 26, 2025

    Report

    Report Number
    2032227-2025-143708
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 26, 2025
    Report Date
    May 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. NO UNEXPECTED PUMP ERROR 63 ALARM NOTED DURING THE TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. FOUND MULTIPLE PUMP ERROR 63 ALARM (VARIABLE 15) FILE NUMBER: 2017, LINE NUMBER: 147 ON 02/26/2025 07:44:15.000 02/26/2025 07:44:26.000 IN THE FILE HISTORY FILES. PUMP 63 ERROR DUE TO HARDWARE ERROR. NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY TUBE, MOTOR, VIBRATOR, AND KEYPAD ASSEMBLY DURING VISUAL INSPECTION. UNIT P-CAP / TEST RESERVOIR LOCK IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: CRACKED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE) AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION, NO PUMP ERROR 63 ALARM DURING TESTING. HOWEVER, PUMP ERROR 63 ALARMS IN HISTORY ON EVENT DATE DUE TO HARDWARE ERROR ELECTRONIC DEFECTIVE. HARDWARE FAULT: SF CHIP TIMEOUT FAILURE. 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

    THE PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. NO UNEXPECTED PUMP ERROR 63 ALARM NOTED DURING THE TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. FOUND MULTIPLE PUMP ERROR 63 ALARM (VARIABLE 15) FILE NUMBER: 2017, LINE NUMBER: 147 ON (B)(6) 2025 07:44:15.000 (B)(6) 2025 07:44:26.000 IN THE FILE HISTORY FILES. PUMP 63 ERROR DUE TO HARDWARE ERROR. NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY TUBE, MOTOR, VIBRATOR, AND KEYPAD ASSEMBLY DURING VISUAL INSPECTION. UNIT P-CAP / TEST RESERVOIR LOCK IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: CRACKED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE) AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION, NO PUMP ERROR 63 ALARM DURING TESTING. HOWEVER, PUMP ERROR 63 ALARMS IN HISTORY ON EVENT DATE DUE TO HARDWARE ERROR ELECTRONIC DEFECTIVE. HARDWARE FAULT: SF CHIP TIMEOUT FAILURE THE PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. NO UNEXPECTED PUMP ERROR 63 ALARM NOTED DURING THE TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. FOUND MULTIPLE PUMP ERROR 63 ALARM (VARIABLE 15) FILE NUMBER: 2017, LINE NUMBER: 147 ON (B)(6) 2025 07:44:15.000 (B)(6) 2025 07:44:26.000 IN THE FILE HISTORY FILES. PUMP 63 ERROR DUE TO HARDWARE ERROR. NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY TUBE, MOTOR, VIBRATOR, AND KEYPAD ASSEMBLY DURING VISUAL INSPECTION. UNIT P-CAP / TEST RESERVOIR LOCK IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: CRACKED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE) AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION, NO PUMP ERROR 63 ALARM DURING TESTING. HOWEVER, PUMP ERROR 63 ALARMS IN HISTORY ON EVENT DATE DUE TO HARDWARE ERROR ELECTRONIC DEFECTIVE. HARDWARE FAULT: SF CHIP TIMEOUT FAILURE.

    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 63 ALARM (HARDWARE LOW LEVEL FAILURES). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED AND ADVISED TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS AND PLACE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001193 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 NG3185346H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female