BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21774914 · Received April 4, 2025

    Report

    Report Number
    2032227-2025-148983
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 29, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FLASHING MEDTRONIC LOGO DURING TESTING. PUMP WAS RECEIVED WITH PUMP ERROR 4 ALARM DURING TESTING. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST, SELF TEST OR VERIFY PUMP ERROR 23, 49, 63, 68 DUE TO PUMP ERROR 4 ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. HOWEVER, SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES FILES. PUMP ERROR 4 CRITICAL HANDLING ALARMS ON (B)(6) 2025 10:29:21.000 LINE NUMBER = 2017, FILE NUMBER = 147 DUE TO HARDWARE ERROR. ALSO FOUND PUMP ERROR 63 ON (B)(6) 2025 10:29:21.000, (B)(6) 2025 10:29:37.000, PUMP ERROR 23 (B)(6) 2025 10:30:14.000, (B)(6) 2025 10:30:34.000, PUMP ERROR 49 (B)(6) 2025 10:29:23.000, (B)(6) 2025 10:29:56.000, (B)(6) 2025 10:30:08.000, PUMP ERROR 68 ON (B)(6) 2025 10:30:14.000, (B)(6) 2025 10:30:34.000 IN FILE HISTORY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY. FLASHING MEDTRONIC LOGO NOT CONFIRMED. PUMP ERROR 4 ALARM DURING TESTING AND PUMP ERROR 4, 23, 49, 63, 68 IN FILE HISTORY DUE TO MOISTURE DAMAGE ELECTRONIC ASSEMBLY CONFIRMED. 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 CUSTOMER EXPERIENCED FLASHING MEDTRONIC LOGO. AND ALSO CUSTOMER RECEIVED THE PUMP ERROR'S 63 (HARDWARE LOW LEVEL FAILURES.), PUMP ERROR 68 (TRACE POINTERS ARE INVALID.), PUMP ERROR 49 (HISTORY POINTERS FAILED. THE HISTORY POINTERS ARE CORRUPTED.) AND PUMP ERROR 23 (POST-RESET RAM CRC ALARM). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR FLASHING MEDTRONIC LOGO ERROR AND CUSTOMER REPORTED A FLASHING MEDTRONIC LOGO ON THE SCREEN THAT WAS NOT A SINGLE FLASH. TROUBLESHOOTING WAS PERFORMED FOR PUMP ERRORS AND CUSTOMER WAS ABLE TO CLEAR THE ERROR AND FILL CANNULA DELIVERY TEST WAS SUCCESSFUL. ERROR TABLE DID NOT INDICATE THAT PUMP SHOULD BE REPLACED AND PUMP PASSED SELF TEST. CUSTOMER WAS NOT USING QUICK BOLUS SPEED FEATURE ON AN IMPACTED PUMP. TROUBLESHOOTING WAS PERFORMED FOR PUMP ERROR 23. CUSTOMER WAS ABLE TO CLEAR THE ERROR AND COMPLETE THE REWIND PROCESS. PUMP WAS RECENTLY STORED, WITHOUT A BATTERY FOR GREATER THAN 8 HOURS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632564 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 NG3761368H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male