BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 700 CHINA  BLE CONNECT 3.0 MMOL/L

    MDR report key: 19593220 · Received June 24, 2024

    Report

    Report Number
    2032227-2024-190909
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 12, 2025
    Manufacturer
    MEDTRONIC-CHENGDU
    Product Code
    OYC
    UDI-DI
    000000763000561680
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN ADDED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION H7 AND H9 WITH THIS REPORT. THE PUMP PASSED THE SELF TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED FOR SEVERAL HOURS WITH A NEW TEST AA 1.5V BATTERY TO ENABLE THE PUMP TO CHARGE. A BATTERY SIMULATOR WAS USED AND CONTINUED TESTING. STILL, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 21:33:19.000, (B)(6) 2024 06:10:26.000, (B)(6) 2024 07:46:18.000, (B)(6) 2024 11:14:00.000, (B)(6) 2024 11:24:00.000. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2024 20:28:00.000, (B)(6) 2024 23:46:00.000, (B)(6) 2024 02:03:00.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2024 06:09:00.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2024 11:25:04.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2024 11:25:17.000, (B)(6) 2024 11:25:25.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT AND REPLACE BATTERY ALERT WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER HAD USED A LOW POWER BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 1 RECEIVED THE LOWBATTERYALERT (104) ON (B)(6) 2024 02:03:00 FASTER THAN EXPECTED AT 1.83 DAYS. BATTERY CYCLE 2 RECEIVED THE LOWBATTERYALERT (104) ON (B)(6) 2024 23:46:00 FASTER THAN EXPECTED AT 2.09 DAYS. BATTERY CYCLE 3 RECEIVED THE LOWBATTERYALERT (104) ON (B)(6) 2024 20:28:00 FASTER THAN EXPECTED AT 2.07 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE, THERE WERE NO OTHER UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE OF 06-JUN-2024 THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR¿ASSEMBLY NOTED. THE ORIGINAL PCBA 1 WAS DISCONNECTED/RECONNECTED WITH THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND NO HIGH SLEEP CURRENT MEASUREMENT NOTED. AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT WAS CONFIRMED, SUSPECTED ON THE PCBA 1/PCBA 2. THE 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 EXCEPT SLEEP CURRENT MEASUREMENT. CUSTOMER ALLEGED FOR CHARGE/BATTERY LASTS LESS THAN EXPECTED AND AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT WERE CONFIRMED, SUSPECTED ON THE PCBA 1/PCBA 2. 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

    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 OUTSIDE 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 THE BATTERY LASTS LESS THAN EXPECTED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1805. TROUBLESHOOTING WAS PARTIALLY PERFORMED, AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN WAS REQUESTED FOR MMT-1805, AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173762 MINIMED 700 CHINA  BLE CONNECT 3.0 MMOL/L PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC-CHENGDU MMT-1805 C190922 000000763000561680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown