BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 21671382 · Received March 22, 2025

    Report

    Report Number
    2032227-2025-140751
    Event Type
    Malfunction
    Date Received
    March 22, 2025
    Date of Event
    March 3, 2025
    Report Date
    August 11, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521547
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT TEST, SLEEP CURRENT MEASUREMENT TEST AND THE DAT TEST AT 0.0871 INCHES. PUMP ERROR 23 WAS NOTED WHICH WAS EXPECTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH WERE NOT IN SPECIFICATION RANGE AND CONFIRMED PUMP ERROR 75 DUE TO MOISTURE EXPOSURE ON THE PCBA 1 J6 CONNECTOR (INTERNAL BATTERY). PUMP ERROR 23 ALARMS WERE FOUND IN THE HISTORY FILES ON 03/03/2025 14:02:48.000 UNTIL 03/03/2025 15:30:32.000. PUMP ERROR 49 ALARMS WERE FOUND IN THE HISTORY FILES ON 03/03/2025 14:02:06.000 UNTIL 03/03/2025 15:30:19.000. PUMP ERROR 68 ALARMS WERE FOUND IN THE HISTORY FILES ON 03/03/2025 14:02:06.000 UNTIL 03/03/2025 15:30:03.000. PUMP ERROR 75 ALARMS WERE FOUND IN THE HISTORY FILES ON 03/03/2025 14:33:24.000 UNTIL 03/03/2025 14:41:03.000. P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE TO THE PCBA 1, PCBA 2 AND INTERNAL BATTERY CONNECTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, SCRATCHED CASE, CRACKED CASE-CORNER OF BELT CLIP RAILS AND LABEL DAMAGE (FADED AND STAINED). PUMP ERROR 23, PUMP ERROR 68, PUMP ERROR 49 AND DEVICE TEST FAILED WERE NOT CONFIRMED DURING TESTING. PUMP ERROR 75 CONFIRMED IN THE PUMP HISTORY FILES AND SEEN IN THE POWER MANAGEMENT GRAPH DUE TO MOISTURE EXPOSURE ON THE PCBA 1 J6 CONNECTOR (INTERNAL BATTERY). 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 68-TRACE POINTERS ARE INVALID, PUMP ERROR 75-POWER SUPPLY TEST FAILED DURING SELF-TEST, PUMP ERROR 49-HISTORY POINTERS FAILED. THE HISTORY POINTERS ARE CORRUPTED, PUMP ERROR 23-POST-RESET RAM CRC ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR THE ERROR AND PUMP DID NOT PASS THE SELF TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1885 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435663 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG5E4ZYZZ 000000763000521547

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Unknown