BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19495786 · Received June 9, 2024

    Report

    Report Number
    2032227-2024-183949
    Event Type
    Injury
    Date Received
    June 9, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 28, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0873 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE 18-MAY-2024 IN THE PUMP HISTORY FILE. 05/18/2024 10:00:48.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 90000 (9 U) BOLUS AMOUNT DELIVERED: 6000 (0.6 U) 05/18/2024 10:04:45.000 NORMALBOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 63000 (6.3 U) BOLUS AMOUNT DELIVERED: 6500 (0.65 U) 05/18/2024 10:09:03.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 100000 (10 U) BOLUS AMOUNT DELIVERED: 2500 (0.25 U) 05/18/2024 10:10:38.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 41000 (4.1 U) BOLUS AMOUNT DELIVERED: 10000 (1 U) 05/18/2024 10:25:14.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 64000 (6.4 U) BOLUS AMOUNT DELIVERED: 4000 (0.4 U) 05/18/2024 10:26:25.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 28000 (2.8 U) BOLUS AMOUNT DELIVERED: 4500 (0.45 U) 05/18/2024 10:32:03.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 10000 (1 U) BOLUS AMOUNT DELIVERED: 2000 (0.2 U) 05/18/2024 12:06:00.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 71000 (7.1 U) BOLUS AMOUNT DELIVERED: 71000 (7.1 U) 05/18/2024 15:19:36.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 45000 (4.5 U) BOLUS AMOUNT DELIVERED: 45000 (4.5 U) 05/18/2024 19:26:49.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1) NORMAL BOLUS AMOUNT PROGRAMMED: 65000 (6.5 U) BOLUS AMOUNT DELIVERED: 65000 (6.5 U) THERE WERE NO AUTOSUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE USER SUSPENDED (2) ALARMS LISTED ON THE EVENT DATE 18-MAY-2024 IN THE PUMP HISTORY FILE. 05/18/2024 10:27:40.000 INSULIN DELIVERY STOPPED (30) REASON FOR INSULIN DELIVERY SUSPENSION: USER SUSPENDED (2) 05/18/2024 10:29:18.000 INSULIN DELIVERY STOPPED (30) REASON FOR INSULIN DELIVERY SUSPENSION: USER SUSPENDED (2) PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 18-MAY-2024 IN THE PUMP HISTORY FILE. 05/18/2024 13:39:54.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: SENSOR ERROR ALERT (801) 05/18/2024 15:44:50.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: SENSOR ERROR ALERT (801) 05/18/2024 15:54:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: SENSOR ERROR ALERT (801) 05/18/2024 17:44:52.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: SENSORE RROR ALERT (801) THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 240 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR SENSOR ERROR ALERT NOTED. SENSOR ERRORALERT (801) - NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS/DKA. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 HYPERGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, DIABETIC KETOACIDOSIS TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION), MANUAL INJECTION/INSULIN PEN, OTHER. CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: CURRENT SENSOR GLUCOSE WAS 344, WAS NOT IN SMART GUARD YET, STILL WAITING ON SMART GUARD WARM UP. CURRENT ACTIVE INSULIN IS 0.7U. INF SETS MMT-397A, LOT 6004662, EXP 11/01/2026. RESERVOIRS MMT-332A, LOT HG7F3W7, EXP 10/05/2026. SENSORS ARE MMT-7040, LOT HG7UZ91, EXP 04/15/2025. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT CUSTOMER REPORTED CUSTOMER WENT INTO DIABETES KETOACIDOSIS AND THE WHEN PLACED PREVIOUS PUMP BACK THE BLOOD GLUCOSE WENT TO NORMAL RANGE IN HUNDREDS AS OPPOSED TO 300 AND 400 WITH NEW PUMP. THE CUSTOMER BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BG EVENT AND USING THE MINIMED 670G/770G/780G SYSTEM WITH THE AUTO MODE/SMART GUARD FEATURE ACTIVE AT TIME OF HIGH BLOOD GLUCOSE EVENT ALARM. THE EVENT INVOLVED PRODUCT(S) MMT-397A, MMT-1884, MMT-332A, MMT-7040A. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE USING THE INSULIN PUMP. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124885 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 NG3734848H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other FRN-MMT-332A-RSVR, OZP- MMT-7040A-SNSR, UNOMED INF