BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 21465910 · Received February 26, 2025

    Report

    Report Number
    2032227-2025-129038
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 3, 2025
    Report Date
    May 19, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000734435
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL BUTTONS FUNCTIONING PROPERLY WHILE NAVIGATING THROUGH THE MENUS. UNIT PASSED THE SELFTEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. THUMP SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY NO DELIVERY ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING THE COMPLAINT CALL. INSULIN FLOW BLOCKED ALARM FOUND IN THE FORMATTED HISTORY FILE ON THE EVENT DATE: 02/03/2025 07:26:33.000 TO 02/03/2025 20:04:00.000 NODELIVERY (7). 02/03/2025 00:34:00.000 NORMALBOLUSDELIVERED (220). EVENTTYPE = 220. SOURCEID = 128. HISTORYRECORDLENGTH = 26. SYSTEMTIME = 02/03/2025 00:34:00.000. BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). BOLUSNUMBER: 190. PRESETBOLUSNUMBER: NONPRESET (0). NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U). BOLUSAMOUNTDELIVERED: 500 (0.05 U). PROCEEDED BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC STACK. ALL CONNECTORS WERE PLUGGED IN PROPERLY AND NO MOISTURE DAMAGE OR ANOMALIES NOTED DURING VISUAL INSPECTION. THE SC1 CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: NO COSMETIC DAMAGE FOUND. NO DELIVERY/OCCLUSION ALARM NOT 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. 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 REPORTED RECURRING INSULIN FLOW BLOCK. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED AND ISSUE WAS UNRESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE. MMT-1885 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026789 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 NG3603430H 000000763000734435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown