BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17667708 · Received September 1, 2023

    Report

    Report Number
    2032227-2023-265606
    Event Type
    Death
    Date Received
    September 1, 2023
    Date of Event
    April 5, 2023
    Report Date
    August 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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. THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08670 INCHES. HOWEVER, THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND 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 SS EVENT DATE OF (B)(6) 2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE SS EVENT DATE (B)(6) 2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U). DAILYTOTALOFBASALINSULINDELIVERED: 0 (0 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 0 (0 U). IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE CUSTOMER'S EVENT DATE OF (B)(6) 2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE CUSTOMER'S EVENT DATE (B)(6) 2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED: 221000 (22.1 U). DAILYTOTALOFBASALINSULINDELIVERED: 221000 (22.1 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 0 (0 U). PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATES (B)(6) 2023 IN THE FORMATTED HISTORY FILE.  SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 09:59:53.000 LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 20:00:00.000, (B)(6) 2023 02:15:00.000, (B)(6) 2023 11:50:00.000, (B)(6) 2023 12:34:00.000, (B)(6) 2023 21:25:00.000. LOSTSENSOR2ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 12:50:00.000, (B)(6) 2023 08:29:00.000, (B)(6) 2023 08:39:00.000. SENSORSIGNALNOTFOUND (796) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 13:27:00.000. 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 SENSOR EXPIRED ALERT, LOST SENSOR ALERT, SENSOR SIGNAL NOT FOUND OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 13:01:18.000, (B)(6) 2023 13:01:37.000, (B)(6) 2023 08:45:53.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 13:01:36.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 08:46:21.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 08:46:30.000, (B)(6) 2023 08:46:38.000, 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 POWER ERROR 25, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM NOTED 1 WEEK PRIOR TO THE EVENT DATES (B)(6) 2023 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS DUE TO BATTERY BACKUP DEPLETION. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, 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 ACTIVE CURRENT MEASUREMENT AND 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 FAILED THE ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WERE CONFIRMED, SUSPECTED ON HW. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.5 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. 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. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE (B)(6) 2023 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 435000 (43.5 U); (B)(6) 2023 DAILYTOTALOFALLINSULINDELIVERED: 492250 (49.225 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 329000 (32.9 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 314250 (31.425 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 284250 (28.425 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 298000 (29.8 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 360000 (36 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 360000 (36 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 221000 (22.1 U); (B)(6) 2023, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U). UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. HOWEVER, A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WERE CONFIRMED, SUSPECTED ON HW. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 PASSED AWAY ON (B)(6) 2023. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CAUSE OF DEATH WAS DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL AT THE TIME OF DEATH WAS 20 MMOL/L. THE CUSTOMER WAS NOT WEARING THE PUMP AT THE TIME OF PASSING AND VOLUNTARILY REMOVED THE INSULIN PUMP TO COMMIT SUICIDE WHICH WAS ADDRESSED IN THE AUTOPSY REPORT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262187 MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1882 HG6FK7BZZ 000000763000545499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death