MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-234492
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- June 21, 2023
- Report Date
- August 7, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000640095
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- 003
Narratives
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 0.0871 INCHES. POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. POSSIBLE UNDER DELIVERY ANOMALY NOT CONFIRMED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND SCRATCHED KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP WAS RECEIVED WITH AN ENERGIZER MAX ALKALINE BATTERY INSTALLED (1.279V). NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. THERE WERE 51 BOLUSES LISTED ON THE EVENT DATE 21-JUN-2023 IN THE PUMP HISTORY FILE. PLEASE SEE THE FIRST 10 BOLUSES BELOW (PRIMARY SVN (B)(4)). 06/21/2023 00:01:20.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/21/2023 00:06:22.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1250 (0.125 U), BOLUSAMOUNTDELIVERED: 1250 (0.125 U). 06/21/2023 00:11:20.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/21/2023 00:16:20.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/21/2023 00:21:20.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/21/2023 00:24:48.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1BGCORRECTIONPLUSFOODBOLUS (8), NORMALBOLUSAMOUNTPROGRAMMED: 49000 (4.9 U), BOLUSAMOUNTDELIVERED: 49000 (4.9 U). 06/21/2023 00:26:19.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U), BOLUSAMOUNTDELIVERED: 750 (0.075 U). 06/21/2023 00:31:19.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/21/2023 00:36:17.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/21/2023 00:41:21.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 21-JUN-2023 (PRIMARY SVN (B)(4)). 06/22/2023 00:00:00.000 DAILYTOTALSG670 (63), DAILYTOTALCOLLECTIONSTARTTIME: 06/21/2023 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED: 632750 (63.275 U), DAILYTOTALOFBASALINSULINDELIVERED: 120750 (12.075 U), DAILYTOTALOFBOLUSINSULINDELIVERED: 512000 (51.2 U). THERE WERE NO AUTO SUSPEND ALARM NOTED ON THE EVENT DATE 21-JUN-2023 IN THE PUMP HISTORY FILE (PRIMARY SVN (B)(4)). PLEASE SEE BELOW FOR THE USER SUSPENDED ALARM LISTED ON THE EVENT DATE 21-JUN-2023 IN THE PUMP HISTORY FILE (PRIMARY SVN (B)(4)). 06/21/2023 11:45:16.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). 06/21/2023 11:45:16.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). THERE WAS NO DATA AVAILABLE ON 14-JAN-2023 ON SVN (B)(4). UNABLE TO VERIFY BOLUS DELIVERY AND ALARMS/SUSPENDS ON THE EVENT DATE 14-JAN-2023 ON SVN (B)(4) DUE TO NO DATA AVAILABLE. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 14-JAN-2023 ON SVN (B)(4). 06/02/2023 00:00:00.000 DAILYTOTALSG670 (63), DAILYTOTALCOLLECTIONSTARTTIME: 06/01/2023 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED: 427000 (42.7 U), DAILYTOTALOFBASALINSULINDELIVERED: 127000 (12.7 U), DAILYTOTALOFBOLUSINSULINDELIVERED: 300000 (30 U). THERE WERE 158 BOLUSES LISTED ON THE EVENT DATE 01-JUN-2023 IN THE PUMP HISTORY FILE ON SVN (B)(4). PLEASE SEE BELOW THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE 01-JUN-2023 IN THE PUMP HISTORY FILE ON SVN (B)(4). 06/01/2023 01:33:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U), BOLUSAMOUNTDELIVERED: 750 (0.075 U). 06/01/2023 01:38:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 01:43:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 01:48:49.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 01:53:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 01:58:49.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 02:03:50.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 02:08:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 02:13:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). 06/01/2023 02:18:51.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5), NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U), BOLUSAMOUNTDELIVERED: 1000 (0.1 U). PLEASE SEE THE USERSUSPENDED ALARM NOTED ON THE EVENT DATE ON THE EVENT DATE 01-JUN-2023 (SVN (B)(4)). 06/01/2023 09:10:41.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). 06/01/2023 10:54:40.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). 06/01/2023 12:22:32.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). THERE WERE NO "AUTOSUSPEND ALARM" IN THE PUMP HISTORY FILE ON THE EVENT DATE 01-JUN-2023 (SVN (B)(4)). PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 21-JUN-2023 IN THE PUMP HISTORY FILE (PRIMARY SVN (B)(4)). 06/15/2023 12:08:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/15/2023 12:34:39.000 BATTERYREMOVED (55). 06/15/2023 12:34:39.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/15/2023 12:35:09.000 BATTERYINSERTED (44). 06/15/2023 16:28:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 06/15/2023 16:38:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 06/21/2023 16:48:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 06/21/2023 16:58:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 7/10/2023 3:56:58 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 06/15/2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. HOWEVER, THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. LOW BATTERY ALERT WAS DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY OR CALIBRATION ANOMALY NOTED. LOWBATTERYALERT (104) NOT CONFIRMED. LOSTSENSOR1ALERT (780) NOT CONFIRMED. UNABLE TO PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 14-JAN-2023 IN THE PUMP HISTORY FILE DUE TO NO DATA AVAILABLE. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 01-JUN-2023 IN THE PUMP HISTORY FILE. ON SVN (B)(4). 05/26/2023 04:55:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 05/26/2023 05:05:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 05/26/2023 07:34:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 05/26/2023 07:38:15.000 BATTERYREMOVED (55). 05/26/2023 07:38:15.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 05/26/2023 07:38:51.000 BATTERYINSERTED (44). 05/26/2023 22:49:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 05/26/2023 22:59:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 7/10/2023 3:56:58 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 05/26/2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. HOWEVER, THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. LOW BATTERY ALERT WAS DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY OR CALIBRATION ANOMALY NOTED. LOSTSENSOR1ALERT (780) NOT CONFIRMED. LOWBATTERYALERT (104) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS/HIGH BGS AND SG VS BG DIFFERENCES. POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. POSSIBLE UNDER DELIVERY ANOMALY (SVN (B)(4)) 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.
(B)(4). 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.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 40 MG/DL AT THE TIME OF THE EVENT AND REPORTED THE PUMP WAS NOT WORKING PROPERLY. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT THE CUSTOMER WAS TREATED IN AN EMERGENCY ROOM. THE CUSTOMER WAS REPORTING SYMPTOMS LIKE UNCONSCIOUSNESS AS A RESULT OF BLOOD GLUCOSE. THE INSULIN PUMP WAS USED WITHIN 48 HOURS AND THE AUTO MODE WAS ACTIVE AT THE TIME OF THE EVENT. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1586662 | 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 | NG3207997H | 000000763000640095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention| H | FRN-MMT-332A-RSVR, UNOMED INF SET |