MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-268402
- Event Type
- Injury
- Date Received
- September 7, 2023
- Date of Event
- July 6, 2023
- Report Date
- December 13, 2023
- 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
- MD, US
- Reporter Occupation
- 003
Narratives
CUSTOMER RETURNED PUMP FOR AN ALLEGED HIGH BGS AND VISIT TO EMERGENCY ROOM FOR LOW BGS FOUND ON (B)(6) 2023 (PER SS EVENT DATE). HOWEVER, THE CUSTOMER'S NOTE STATED THAT THE CUSTOMER RETURNED PUMP FOR AN ALLEGED HIGH BGS AND VISIT TO EMERGENCY ROOM FOR LOW BGS FOUND ON (B)(6) 2023. ON CASE: (B)(4), SVN#: (B)(6), CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER/OVER DELIVERY ANOMALY AND VISIT TO EMERGENCY ROOM FOR HIGH BGS/LOW BGS FOUND ON (B)(6) 2023. 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 0.08730 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 (SS) EVENT DATE OF 09-AUG-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 09-AUG-2023 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED: 251750 (25.175 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 132750 (13.275 U). DAILY TOTAL OF BOLUS INSULIN DELIVERED: 119000 (11.9 U). ON (B)(6) 2023 03:44:55.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 11000 (1.1 U). BOLUS AMOUNT DELIVERED: 11000 (1.1 U). ON (B)(6) 2023 06:40:50.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 3000 (0.3 U). BOLUS AMOUNT DELIVERED: 3000 (0.3 U). ON (B)(6) 2023 07:35:46.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 14000 (1.4 U). BOLUS AMOUNT DELIVERED: 14000 (1.4 U). ON (B)(6) 2023 11:12:01.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 3000 (0.3 U). BOLUS AMOUNT DELIVERED: 3000 (0.3 U). ON (B)(6) 2023 12:03:50.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 43000 (4.3 U). BOLUS AMOUNT DELIVERED: 43000 (4.3 U). ON (B)(6) 2023 14:33:45.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 3000 (0.3 U). BOLUS AMOUNT DELIVERED: 3000 (0.3 U). ON (B)(6) 2023 14:34:10.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 6000 (0.6 U). BOLUS AMOUNT DELIVERED: 6000 (0.6 U). ON (B)(6) 2023 16:11:26.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 BG CORRECTION PLUS FOOD BOLUS (8). NORMAL BOLUS AMOUNT PROGRAMMED: 19000 (1.9 U). BOLUS AMOUNT DELIVERED: 19000 (1.9 U). ON (B)(6) 2023 19:04:32.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 BG CORRECTION PLUS FOOD BOLUS (8). NORMAL BOLUS AMOUNT PROGRAMMED: 17000 (1.7 U). BOLUS AMOUNT DELIVERED: 17000 (1.7 U). IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE (CUSTOMER'S) EVENT DATE OF 06-AUG-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 06-AUG-2023 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED: 294000 (29.4 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 152000 (15.2 U). DAILY TOTAL OF BOLUS INSULIN DELIVERED: 142000 (14.2 U). ON (B)(6) 2023 02:45:25.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 28000 (2.8 U). BOLUS AMOUNT DELIVERED: 28000 (2.8 U). ON (B)(6) 2023 04:55:03.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 28000 (2.8 U). BOLUS AMOUNT DELIVERED: 28000 (2.8 U). ON (B)(6) 2023 06:41:01.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 5000 (0.5 U). BOLUS AMOUNT DELIVERED: 5000 (0.5 U). ON (B)(6) 2023 09:12:06.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 31000 (3.1 U). BOLUS AMOUNT DELIVERED: 31000 (3.1 U). ON (B)(6) 2023 11:49:50.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 BG CORRECTION PLUS FOOD BOLUS (8). NORMAL BOLUS AMOUNT PROGRAMMED: 19000 (1.9 U). BOLUS AMOUNT DELIVERED: 19000 (1.9 U). ON (B)(6) 2023 15:22:21.000 NORMAL BOLUS DELIVERED (2). BOLUS PROGRAMMING METHOD: CL1 FOOD BOLUS (7). NORMAL BOLUS AMOUNT PROGRAMMED: 2000 (0.2 U). BOLUS AMOUNT DELIVERED: 2000 (0.2 U). ON (B)(6) 2023 16:03:26.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 BG CORRECTION PLUS FOOD BOLUS (8). NORMAL BOLUS AMOUNT PROGRAMMED: 9000 (0.9 U). BOLUS AMOUNT DELIVERED: 9000 (0.9 U). ON (B)(6) 2023 18:00:07.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: CL1 BG CORRECTION PLUS FOOD BOLUS (8). NORMAL BOLUS AMOUNT PROGRAMMED: 20000 (2 U). BOLUS AMOUNT DELIVERED: 20000 (2 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 (SS) EVENT DATE 09-AUG-2023 AND (CUSTOMER'S) EVENT DATE 06-AUG-2023 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 13:20:00.000, ON (B)(6) 2023 13:30:00.000, ON (B)(6) 2023 22:29:00.000, ON (B)(6) 2023 23:25:00.000, ON (B)(6) 2023 05:08:00.000, ON (B)(6) 2023 05:45:00.000. SG CALIBRATION ERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: ON (B)(6) 2023 16:20:14.000, ON (B)(6) 2023 06:41:46.000, ON (B)(6) 2023 16:11:42.000. SENSOR ERROR ALERT (801) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: ON (B)(6) 2023 07:58:57.000, ON (B)(6) 2023 08:28:58.000, ON (B)(6) 2023 09:03:57.000, ON (B)(6) 2023 19:58:59.000, ON (B)(6) 2023 20:08:00.000. 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 LOST SENSOR ALERT, SG CALIBRATION ERROR, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 09:12:00.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 10:04:05.000. 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. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2023 AT 1:59:58 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE ON (B)(6) 2023 AT 09:12:00.000. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. NO UNEXPECTED LOW BATTERY ALERT NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITH 1.137V DURACELL ALKALINE BATTERY INSTALLED. THE 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 HIGH BGS/LOW BGS. CUSTOMER ALLEGED FOR POSSIBLE UNDER/OVER DELIVERY ANOMALY WAS NOT CONFIRMED. 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.
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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5,H6 (HECC, HEIC) WITH THIS REPORT.
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, 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.
UPDATED SUMMARY: THIS CASE IS THE HYPOGLYCEMIC EVENT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 300 MG/DL. THE CUSTOMER ALSO EXPERIENCED HYPOGLYCEMIA WITH A LOW BLOOD GLUCOSE EVENT AND VISITED TO THE EMERGENCY ROOM. THE CUSTOMER WAS DECLINED FOR TROUBLESHOOTING. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. IT WAS UNKNOWN WHETHER THE AUTO-MODE FEATURE WAS ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN AS PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1560639 | 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 | NG3242448H | 000000763000640095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention| O | FRN-MMT-332A-RSVR, UNOMED INF SET, OZP-MMT-7020-SN. |