BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 18071160 · Received November 6, 2023

    Report

    Report Number
    2032227-2023-297237
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 14, 2023
    Report Date
    December 3, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08710 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. 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 14-OCT-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 14-OCT-2023 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED: 453750 (45.375 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 138750 (13.875 U). DAILY TOTAL OF BOLUS INSULIN DELIVERED: 315000 (31.5 U). NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 12:54:15.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 18:05:22.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 18:10:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 18:12:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 18:14:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 18:16:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 21:39:26.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 21:58:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 21:59:48.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 22:00:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 22:12:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 22:22:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 22:24:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 22:28:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 22:33:10.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 23:06:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 23:16:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. 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 UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 14-OCT-2023 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 23:16:04.000. ON (B)(6) 2023 23:21:36.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 12:51:00.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 23:20:28.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 23:23:58.000. 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 NOTED. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2023. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES ON (B)(6) 2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND PUMP ERROR 23 ALARM. NO UNEXPECTED LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND PUMP ERROR 23 ALARM NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.5 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP INSTALLED. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. HOWEVER, A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    (B)(4). 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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 600 MG/DL AT THE TIME OF THE EVENT. THE CURRENT BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER REPORTED LETHARGIC, VERY THIRSTY SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER REPORTED AN INSULIN FLOW BLOCKED ALARM. THE CUSTOMER WAS ADMITTED TO THE EMERGENCY ROOM. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT AND THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER DISCONTINUED USING THE PUMP AND IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221837 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 HG672DFZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention FRN-MMT-332A-RSVR, UNOMED-INF SET.