BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21781557 · Received April 5, 2025

    Report

    Report Number
    2032227-2025-149398
    Event Type
    Injury
    Date Received
    April 5, 2025
    Date of Event
    March 11, 2025
    Report Date
    June 16, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE FUNCTIONAL TESTS, 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 DAT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 01/19/2025 TO 03/09/2025. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND DAILY TOTAL OF BASAL/BOLUS DELIVERY FOR THE EVENT DATE OF 11-MAR-2025. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR SURROUNDING THE DATE OF 09-MAR-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: 03/08/2025 03:05:26.000, 03/08/2025 03:05:44.000. 03/09/2025 21:13:41.000, 03/09/2025 21:13:41.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 03/08/2025 03:05:36.000. 03/09/2025 21:13:41.000. LOW BATTERY ALERT WAS FOUND ON: 03/08/2025 03:04:01.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A LOW/NO POWER BATTERY. UNABLE TO TEST FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT WERE UNKNOWN. LOSTSENSOR1ALERT (780) WAS FOUND ON: 03/07/2025 16:16:00.000. SENSORERRORALERT (801) WAS FOUND ON: 03/08/2025 06:48:46.000. UNABLE TO TEST FOR LOST SENSOR ALERT AND SENSOR ERROR ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT AND SENSOR ERROR ALERT WERE UNKNOWN. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON 03/09/2025 21:10:01.000 AND 03/09/2025 21:20:00.000. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT, A SERIAL NUMBER LABEL MISSING AND A BROKEN BELT CLIP RAILS. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. UNABLE TO UPLOAD PUMP TO CARELINK AND PERFORM THE REQUIRED TESTING DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM.CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. 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 HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS (DKA) DUE TO CRITICAL PUMP ERROR. THE CUSTOMER REPORTED HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS TREATED WITH EMERGENCY ROOM VISIT, INTRAVENOUS INSULIN DRIP (INTRAVENOUS INSULIN INFUSION) AND INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION) AND ALSO REPORTED SYMPTOMS OF CONFUSION AND FEELING SICK. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-1884, UNOMEDICAL. TROUBLESHOOTING ON CRITICAL PUMP ERROR CONFIRMED THAT CUSTOMER WAS USING CORRECT BATTERY CAP AND NO SIGNS OF PHYSICAL DAMAGE. FURTHER TROUBLESHOOTING ON HYPERGLYCEMIC EVENT WAS PARTIALLY COMPLETED AND THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT AND THE INSULIN PUMP SYSTEM WAS IN USE WITHIN 48HRS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942854 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 HG5W7PYZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention FRN-MMT-332A-RSVR, UNOMED INF SET