BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 720G OUS BLE CONNECT 3.0 MGDL

    MDR report key: 20808500 · Received November 29, 2024

    Report

    Report Number
    2032227-2024-277114
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    October 9, 2024
    Report Date
    May 13, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000475918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). PROCEEDED WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. UNIT PASSED DISPLACEMENT TEST, SELF TEST, SLEEP AND ACTIVE CURRENT MEASUREMENT TEST. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAIN CALL THAT MIGHT OF TRIGGER THE REASON COMPLAIN. THE ADAPT TOOL REVEALS THAT PUMP ERROR 53 ALARM WAS FOUND ON (B)(6) 2024 10:17:08.000 FILE: (B)(5), LINE: 382. PER SOFTWARE ENGINEERING LOG INVESTIGATION, IT WAS DETERMINED THAT PUMP ERROR 53 WAS CAUSE BY INVALID POINTER/CORRUPTED DATA ESF#: (LWD 4812707). NO LOW BATTERY ALARMS OR UNEXPECTED BATTERY POWER LOSS NOTED DURING TESTING. UNIT FUNCTIONING PROPERLY. THE POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED THE UNLOADED VOLTAGE (UNLOADED VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. THE FOLLOWING LOW BATTERY ALERTS WERE RECORDED: ON (B)(6) 2024 20:02:00.000, ON (B)(6) 2024 13:39:00.000, ON (B)(6) 2024 19:57:00.000 AND ON (B)(6) 2024 00:25:00.000. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, THE CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED BATTERY POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. PROCEEDED BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. UNIT ALSO RECEIVED WITH SCRATCHED CASE, LABEL DAMAGE (FADED) AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION UNIT POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO FROZEN SCREEN, BLANK DISPLAY OR LOW BATTERY RELATED ALARMS NOTED. HOWEVER, DURING DOWNLOAD HISTORY REVIEW PUMP ERROR 53 WAS RECORDED. UNEXPECTED BATTERY POWER LOSS AND CHARGE/BATTERY LASTS LESS THAN EXPECTED WAS NOT CONFIRMED. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLIES. 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. 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. 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 FROZEN SCREEN, E/A ALARM UNSPECIFIED, UNEXPECTED BATTERY POWER LOSS, BLANK DISPLAY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1810. TROUBLESHOOTING WAS PERFORMED. CUSTOMER UNABLE TO FULLY RESET PUMP AFTER REMOVING BATTERY NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1810 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438724 MINIMED 720G OUS BLE CONNECT 3.0 MGDL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1810 HG5YLV2ZZ 000000763000475918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown