BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19284859 · Received May 10, 2024

    Report

    Report Number
    2032227-2024-167517
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 3, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000640095
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 0.0872 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. TEST P-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. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE NO DELIVERY ALARM LISTED ON THE EVENT DATE 23-APR-2024 IN THE PUMP HISTORY FILE IN THE PRIMARY SVN (B)(6). 04/23/2024 16:29:54.000 ALARMALERTNOTIFICATION (40). SYSTEMTIME = 04/23/2024 16:29:54.000. FAULTNUMBER: NODELIVERY (7) ¿ DURING BOLUS. 04/23/2024 16:43:28.000 ALARMALERTNOTIFICATION (40). SYSTEMTIME = 04/23/2024 16:43:28.000. FAULTNUMBER: NODELIVERY (7) ¿ DURING BOLUS. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATE 23-APR-2024 IN THE PUMP HISTORY FILE IN THE PRIMARY SVN (B)(6). 04/23/2024 16:27:48.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). NORMALBOLUSAMOUNTPROGRAMMED: 11000 (1.1 U). BOLUSAMOUNTDELIVERED: 11000 (1.1 U). 04/23/2024 16:29:54.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 95000 (9.5 U). BOLUSAMOUNTDELIVERED: 47000 (4.7 U). 04/23/2024 16:43:28.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). NORMALBOLUSAMOUNTPROGRAMMED: 50000 (5 U). BOLUSAMOUNTDELIVERED: 29000 (2.9 U). 04/23/2024 21:28:05.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). NORMALBOLUSAMOUNTPROGRAMMED: 13000 (1.3 U). BOLUSAMOUNTDELIVERED: 13000 (1.3 U). PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 23-APR-2024 IN THE PUMP HISTORY FILE IN THE PRIMARY SVN (B)(6). 04/24/2024 00:00:00.000 DAILYTOTALSG670 (63). DAILYTOTALCOLLECTIONSTARTTIME: 04/23/2024 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 211750 (21.175 U). DAILYTOTALOFBASALINSULINDELIVERED: 111750 (11.175 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 100000 (10 U). THERE WERE NO AUTOSUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE IN THE PRIMARY SVN (B)(6). THERE WERE NO USERSUSPENDED (2) ALARM NOTED ON THE EVENT DATE 23-APR-2024 IN THE PUMP HISTORY FILE IN THE PRIMARY SVN (B)(6). PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 23-APR-2024 IN THE PUMP HISTORY FILE IN THE PRIMARY SVN (B)(6). 04/17/2024 15:41:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: LOSTSENSOR1ALERT (780). 04/17/2024 15:51:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: LOSTSENSOR1ALERT (780). 04/23/2024 16:29:54.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: NODELIVERY (7) ¿ DURING BOLUS. 04/23/2024 16:43:28.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: NODELIVERY (7) ¿ DURING BOLUS. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO ENTER AUTO MODE. THE AUTO MODE SHIELD WITH THE TEST SG VALUE OF 240 MG/DL WAS DISPLAYED ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, AUTO MODE ANOMALY, OR LOST SENSOR ALERT NOTED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. LOSTSENSOR1ALERT (780) - NOT CONFIRMED. NODELIVERY (7) - NOT CONFIRMED. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE ON 09-MAR-2024 ON SVN (B)(6). 03/09/2024 09:01:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: LOWBATTERYALERT (104). 03/09/2024 10:51:15.000 BATTERYREMOVED (55). 03/09/2024 10:51:15.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: BATTERYREMOVED (84). 03/09/2024 10:52:55.000 BATTERYINSERTED (44). 03/09/2024 14:42:21.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: SENSORERRORALERT (801). 03/09/2024 15:12:22.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: SENSORERRORALERT (801). 03/09/2024 15:47:21.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: SENSORERRORALERT (801). 03/09/2024 16:17:21.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: CHANGESENSOR1ALERT (777). 03/09/2024 16:27:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: CHANGESENSOR1ALERT (777). THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 4/23/2024 1:38:57 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF 03/09/2024. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO ENTER AUTO MODE. THE AUTO MODE SHIELD WITH THE TEST SG VALUE OF 240 MG/DL WAS DISPLAYED ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, AUTO MODE ANOMALY, AUTO MODE REPEATED BG REQUEST ANOMALY, SENSOR ERROR ALERT OR CHANGE SENSOR ALERT/BAD SENSOR ALERT NOTED. LOWBATTERYALERT (104) - UNKNOWN. SENSORERRORALERT (801) - NOT CONFIRMED. CHANGESENSOR1ALERT (777) - NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS (HYPERGLYCEMIA) PRIMARY SVN (B)(6). INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED PRIMARY SVN (B)(6). CHANGE SENSOR/BAD SENSOR ALERT NOT CONFIRMED (SVN (B)(6)). AUTO MODE REPEATED BG REQUEST ANOMALY NOT CONFIRMED (SVN (B)(6)). AUTO MODE ANOMALY NOT CONFIRMED (SVN (B)(6)). 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. 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 HYPERGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 650 MG/DL AND TREATED WITH TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), HOSPITALIZATION: OVERNIGHT STAY, MANUAL INJECTION/INSULIN PEN. THE EVENT INVOLVED PRODUCT(S) MMT-1880, UNOMEDICAL. TROUBLESHOOTING WAS PERFORMED AND REPORTED SYMPTOMS OF FEELING SICK/ UNWELL DURING THE TIME OF HOSPITALIZATION. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE USING THE INSULIN PUMP. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880202 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 NG3291286H 000000763000640095

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| O| H UNOMED INF SET.