BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19368401 · Received May 22, 2024

    Report

    Report Number
    2032227-2024-174615
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 2, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08445 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 2022, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF (B)(6) 2022 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2022 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U), DAILYTOTALOFBASALINSULINDELIVERED: 0 (0 U), DAILYTOTALOFBOLUSINSULINDELIVERED: 0 (0 U). THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2022 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF (B)(6) 2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF (B)(6) 2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2024 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED: 423250 (42.325 U), DAILYTOTALOFBASALINSULINDELIVERED: 82250 (8.225 U), DAILYTOTALOFBOLUSINSULINDELIVERED: 341000 (34.1 U). (B)(6) 2024 15:03:43.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 153250 (15.325 U), BOLUSAMOUNTDELIVERED: 153250 (15.325 U). (B)(6) 2024 21:17:17.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 187750 (18.775 U), BOLUSAMOUNTDELIVERED: 187750 (18.775 U). THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2024 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 14:01:55.000 POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. NO PUMP/SENSOR/TRANSMITTER COMMUNICATION ANOMALY NOTED. THE PUMP PROPERLY PAIRED TO MINIMED MOBILE APP ON A SAMSUNG GALAXY S21 PHONE AND APPLE IPHONE 12. NO PUMP/MOBILE (BLUETOOTH) COMMUNICATION ANOMALY NOTED. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. 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. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS. CUSTOMER ALLEGED FOR POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED. CUSTOMER ALLEGED FOR PUMP/SENSOR/TRANSMITTER COMMUNICATION ANOMALY AND PUMP/MOBILE (BLUETOOTH) COMMUNICATION ANOMALY WERE 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

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 HYPOGLYCEMIA WITH BLOOD GLUCOSE VALUE: UNKNOWN MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-1880, MMT-332A, MMT-399A. TROUBLESHOOTING WAS NOT PERFORMED. THE CUSTOMER REPORTED LOW BLOOD GLUCOSE EVENT. IT WAS UNKNOWN WHETHER THE INSULIN PUMP WAS USED WITHIN 48 HOURS AND UNKNOWN WHETHER THE AUTO MODE/SMART GUARD FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PRODUCT RETURN IS REQUIRED FOR MMT-1880. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-399A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704582 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 HG5U66UZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention| O| H FRN-MMT-332A-RSVR, UNOMED INF SET.