BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20999408 · Received December 23, 2024

    Report

    Report Number
    2032227-2024-292784
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 30, 2024
    Report Date
    March 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.0875 INCHES. THE PUMP POWERED UP PROPERLY AFTER THE TEST BATTERY WAS INSERTED. THE PUMP WAS MONITORED FOR 2 DAYS. NO BLANK DISPLAY OR FROZEN SCREEN NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE PUMP WAS RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. THERE WERE NO BOLUSES LISTED ON THE EVENT DATE 30-NOV-2024 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 30-NOV-2024 IN THE PUMP HISTORY FILE. (B)(6)2024 00:00:00.000 DAILYTOTALS (60) DAILYTOTALCOLLECTIONSTARTTIME: (B)(6)2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U) DAILYTOTALOFBASALINSULINDELIVERED: 0 (0 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 0 (0 U) THERE WERE NO AUTOSUSPEND ALARM NOTED IN THE PUMP HISTORY FILE. THERE WERE NO USERSUSPENDED (2) ALARM NOTED ON THE EVENT DATE 30-NOV-2024 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 30-NOV-2024 IN THE PUMP HISTORY FILE. (B)(6)2024 16:02:54.000 BATTERYREMOVED (55) (B)(6)2024 16:02:54.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 16:05:25.000 BATTERYINSERTED (44) (B)(6)2024 16:05:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 16:05:50.000 BATTERYREMOVED (55) (B)(6)2024 16:05:50.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 16:06:49.000 BATTERYINSERTED (44) (B)(6)2024 16:06:49.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 17:00:05.000 BATTERYREMOVED (55) (B)(6)2024 17:00:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 17:01:16.000 BATTERYINSERTED (44) (B)(6)2024 17:01:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 17:01:18.000 BATTERYREMOVED (55) (B)(6)2024 17:01:18.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 17:01:21.000 BATTERYINSERTED (44) (B)(6)2024 17:01:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 17:01:30.000 BATTERYREMOVED (55) (B)(6)2024 17:01:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 17:11:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 17:32:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 17:42:01.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 17:42:32.000 BATTERYREMOVED (55) (B)(6)2024 17:42:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 17:42:49.000 BATTERYINSERTED (44) EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6)2024 8:32:55 PMTHERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF (B)(6)2024. UNABLE TO CHECK POWER DATA FOR FAILED BATT/BATTERY FAILED ALARM AND BATTOUTLIMIT (6). THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. FAILEDBATTTEST (58) UNKNOWN. BATTOUTLIMIT (6) UNKNOWN. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.0 MV). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS (HYPERGLYCEMIA). BLANK DISPLAY NOT CONFIRMED. FROZEN SCREEN NOT CONFIRMED. 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

    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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 BLANK DISPLAY, FROZEN SCREEN. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 700 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH HOSPITALIZATION: OVERNIGHT STAY. CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: NO TROUBLESHOOTING WAS IDENTIFIED. THE EVENT INVOLVED PRODUCT(S) MMT-1812. VER AX, DISPLAY BLANK, FROZEN, PARTIAL SCREEN, FLASHING/SOLID WHITE SCREEN T/S CUSTOMER REPORTED A FROZEN DISPLAY. CUSTOMER CALLED BACK AFTER RESTING PUMP FOR 2 HOURS AND REPLACING BATTERY. FROZEN DISPLAY CONTINUED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS . MMT-1812 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624482 MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1812 NG3656314H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown