BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 700 CHINA  BLE CONNECT 3.0 MMOL/L

    MDR report key: 22410543 · Received July 7, 2025

    Report

    Report Number
    2032227-2025-205851
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 11, 2025
    Report Date
    January 21, 2026
    Manufacturer
    MEDTRONIC-CHENGDU
    Product Code
    OYC
    UDI-DI
    000000763000561680
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED AND NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. 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 FOUND ON: (B)(6) 2025 22:11:25.000, (B)(6) 2025 20:36:52.000, (B)(6) 2025 09:11:49.000 TO (B)(6) 2025 17:34:54.000, LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2025 12:32:00.000, (B)(6) 2025 17:50:00.000, (B)(6) 2025 14:46:00.000, REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2025 17:18:09.000, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2025 09:20:48.000, (B)(6) 2025 11:51:34.000 TO (B)(6) 2025 11:54:11.000, (B)(6) 2025 13:04:04.000 TO (B)(6) 2025 13:41:37.000, (B)(6) 2025 14:03:21.000, (B)(6) 2025 14:04:15.000, (B)(6) 2025 15:17:46.000 TO (B)(6) 2025 15:30:00.000, (B)(6) 2025 17:05:27.000 TO (B)(6) 2025 17:34:09.000, POWER LOSS ALARM WAS FOUND ON: (B)(6) 2025 13:41:14.000, (B)(6) 2025 15:30:10.000, (B)(6) 2025 17:35:49.000, PUMP ERROR 68 ALARM WAS FOUND ON: (B)(6) 2025 17:35:13.000, PUMP ERROR 49 ALARM WAS FOUND ON: (B)(6) 2025 17:35:13.000, (B)(6) 2025 17:35:27.000, PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2025 17:35:37.000, 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, LOW BATTERY ALERT, REPLACE BATTERY ALERT AND POWER LOSS ALARM 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/DEPLETED BATTERY. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE EXPECTED SINCE THE PUMP RESTARTED AFTER PUMP SHUTDOWN. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM, LOW BATTERY ALERT, REPLACE BATTERY ALERT, POWER LOSS ALARM, PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM NOTED DURING TESTING. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE, THERE WERE NO OTHER UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE OF (B)(6) 2025. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE VIBRATOR ASSEMBLY NOTED. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS NOT CONFIRMED. HOWEVER, DURING VISUAL INSPECTION CORROSION WAS FOUND ON THE VIBRATOR ASSEMBLY NOTED. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. 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

    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. 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 REPORTED RECEIVING A BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1805. TROUBLESHOOTING WAS NOT PERFORMED. NO DAMAGE WAS REPORTED ON BATTERY CAP CONTACTS OR BATTERY COMPARTMENT. THE CUSTOMER CONTINUED TO RECEIVE BATTERY FAILED ALARMS AFTER INSERTING NEW BATTERIES, RESTARTING THE PUMP, AND USING A REPLACEMENT BATTERY CAP. THE CUSTOMER WAS ADVISED THAT THE PUMP WOULD BE REPLACED. BATTERY FAILED ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-1805 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762250 MINIMED 700 CHINA  BLE CONNECT 3.0 MMOL/L PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC-CHENGDU MMT-1805 C081123 000000763000561680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown