MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-184768
- Event Type
- Injury
- Date Received
- April 10, 2023
- Date of Event
- March 21, 2023
- Report Date
- April 9, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000414344
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY AND HIGH BGS FOUND ON (B)(6) 2023 ON (B)(4). , SVN#: (B)(4). - CUSTOMER RETURNED PUMP FOR AN ALLEGED BATTERY CAP CONTACT MISSING/DAMAGED FOUND ON (B)(6) 2022. 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 0.08710 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 (B)(6) 2023 , THERE IS NO UNEXPECTED ALARMS/SUSPENDS NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE (B)(6) 2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED: 496000 (49.6 U). DAILYTOTALOFBASALINSULINDELIVERED: 201500 (20.15 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 294500 (29.45 U). (B)(6) 2023 04:46:45.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 12000 (1.2 U). BOLUSAMOUNTDELIVERED: 12000 (1.2 U). (B)(6) 2023 08:10:39.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 13000 (1.3 U). BOLUSAMOUNTDELIVERED: 13000 (1.3 U). (B)(6) 2023 11:37:10.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 61000 (6.1 U). BOLUSAMOUNTDELIVERED: 1000 (0.1 U). (B)(6) 2023 11:37:10.000, A BOLUS DELIVERY OF (6.1 U) WAS CANCELLED BY THE USER AND THE BOLUS AMOUNT DELIVERED WAS (0.1 U). (B)(6) 2023 11:41:09.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 55000 (5.5 U). BOLUSAMOUNTDELIVERED: 55000 (5.5 U). (B)(6) 2023 12:20:39.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 14000 (1.4 U). BOLUSAMOUNTDELIVERED: 14000 (1.4 U). (B)(6) 2023 13:00:57.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U) BOLUSAMOUNTDELIVERED: 0 (0 U). ON (B)(6) 2023 13:00:57.000, A BOLUS DELIVERY OF (0.1 U) WAS CANCELLED BY THE USER AND THE BOLUS AMOUNT DELIVERED WAS (0 U). (B)(6) 2023 13:17:10.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 3000 (0.3 U). BOLUSAMOUNTDELIVERED: 3000 (0.3 U). (B)(6) 2023 14:10:35.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 16000 (1.6 U). BOLUSAMOUNTDELIVERED: 16000 (1.6 U). (B)(6) 2023 14:41:11.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 21000 (2.1 U) BOLUSAMOUNTDELIVERED: 21000 (2.1 U). (B)(6) 2023 14:50:59.000 NORMALBOLUSDELIVERED (220) . NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U). BOLUSAMOUNTDELIVERED: 0 (0 U). ON (B)(6) 2023 14:50:59.000, A BOLUS DELIVERY OF (0.1 U) WAS CANCELLED BY THE USER AND THE BOLUS AMOUNT DELIVERED WAS (0 U). (B)(6) 2023 14:53:11.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 26000 (2.6 U). BOLUSAMOUNTDELIVERED: 26000 (2.6 U). (B)(6) 2023 17:30:45.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 61000 (6.1 U). BOLUSAMOUNTDELIVERED: 45500 (4.55 U) ON (B)(6) 2023 17:30:45.000, A BOLUS DELIVERY OF (6.1 U) WAS CANCELLED BY THE USER AND THE BOLUS AMOUNT DELIVERED WAS (4.55 U). (B)(6) 2023 17:41:22.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 12000 (1.2 U). BOLUSAMOUNTDELIVERED: 12000 (1.2 U). (B)(6) 2023 17:46:18.000 NORMALBOLUSDELIVERED (220). NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U). BOLUSAMOUNTDELIVERED: 5000 (0.5 U). (B)(6) 2023 22:31:14.000 NORMALBOLUSDELIVERED (220) . NORMALBOLUSAMOUNTPROGRAMMED: 71000 (7.1 U). BOLUSAMOUNTDELIVERED: 71000 (7.1 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) 2023 IN THE FORMATTED HISTORY FILE. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 10:26:00.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 10:54:26.000 BATTERYREMOVED (84) 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. NO POWER ERROR 25, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE FORMATTED HISTORY FILE. 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 8:00:59 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF (B)(6) 2023.UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 15:21:46.000. LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 16:06:00.000. (B)(6) 2023 09:06:00.000. LOSTSENSOR2ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 16:24:00.000. SGCALIBRATIONERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 10:25:45.000. (B)(6) 2023 01:39:27.000. 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 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS/ALERT 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 CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS NOT CONFIRMED. BATTERY CAP CONTACT MISSING/DAMAGED 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.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH THE BLOOD GLUCOSE VALUE OF 600 MG/DL. THE CURRENT BLOOD GLUCOSE VALUE WAS 207 MG/DL. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER ALLEGES POSSIBLE UNDER DELIVERY OF INSULIN. CUSTOMER REPORTED HEADACHE SYMPTOM RELATED TO HYPERGLYCEMIA. CUSTOMER WAS TAKEN TO EMERGENCY ROOM TO TREAT HYPERGLYCEMIA AND WAS TREATED WITH INTRAVENOUS INSULIN DRIP. THE PUMP WAS USED WITHIN THE 48 HOURS OF THE REPORTED EVENT AND SMART GUARD/AUTO MODE WAS ACTIVE AT THE TIME OF EVENT. CUSTOMER WAS ADVISED TO DISCONTINUE THE PUMP USAGE AND REVERT TO BACK UP PLAN AS PER HEALTHCARE PROFESSIONAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519498 | 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 | HG5AFQDZZ | 000000763000414344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention | FRN-MMT-332-RSVR, UNOMED SET, OZP-MMT-7020-SNSR |