BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 700 CHINA  BLE CONNECT 3.0 MMOL/L

    MDR report key: 19708565 · Received July 10, 2024

    Report

    Report Number
    2032227-2024-200186
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 18, 2025
    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

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE LOT NUMBER. THE ADDITIONAL INFORMATION HAS BEEN UPDATED IN SECTION D4 (LOT NUMBER C230823 SUBMITED IN THE INITIAL REPORT HAS BEEN UPDATED TO BLANK). FLASHING MEDTRONIC LOGO DISPLAY, PROBLEM ISOLATED TO THE PCB1 BOARD AND PCB2 BOARD. NO FROZEN DISPLAY NOTED. UNABLE TO PERFORM SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT TEST DUE TO FLASHING DISPLAY. NO MOISTURE DAMAGE NOTED TO THE MOTOR ASSEMBLY, PCB1 BOARD OR PCB 2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. CONFIRMED FLASHING MEDTRONIC LOGO DISPLAY AFTER BATTERY INSTALLATION PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY. NO FROZEN DISPLAY 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. 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 FROZEN SCREEN. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1805. TROUBLESHOOTING WAS NOT PERFORMED. CUSTOMER REPORTED A FROZEN DISPLAY. CUSTOMER CALLED BACK AFTER RESTING PUMP FOR 2 HOURS AND REPLACING BATTERY. FROZEN DISPLAY CONTINUED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1805 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962168 MINIMED 700 CHINA  BLE CONNECT 3.0 MMOL/L PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC-CHENGDU MMT-1805 C230823 000000763000561680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown