MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2022-356417
- Event Type
- Injury
- Date Received
- November 7, 2022
- Date of Event
- October 12, 2022
- Report Date
- January 12, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. RETAINER RING = BLACK. CASE TYPE = NGP CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE OVER DELIVERY AND LOW BGS FOUND ON 12-OCT-2022. 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 0.08730 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 12-OCT-2022, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND BOLUS DELIVERY OF DAILYTOTALOFBOLUSINSULINDELIVERED: (39.5 U). 10/12/2022 02:05:55.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 47000 (4.7 U) BOLUSAMOUNTDELIVERED: 47000 (4.7 U) 10/12/2022 06:10:55.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 70000 (7 U) BOLUSAMOUNTDELIVERED: 70000 (7 U) 10/12/2022 08:09:19.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 69000 (6.9 U) BOLUSAMOUNTDELIVERED: 69000 (6.9 U) 10/12/2022 12:15:39.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 8000 (0.8 U) BOLUSAMOUNTDELIVERED: 8000 (0.8 U) 10/12/2022 12:20:23.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 4000 (0.4 U) BOLUSAMOUNTDELIVERED: 4000 (0.4 U) 10/12/2022 12:30:23.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 4000 (0.4 U) BOLUSAMOUNTDELIVERED: 4000 (0.4 U) 10/12/2022 12:35:26.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 3000 (0.3 U) BOLUSAMOUNTDELIVERED: 3000 (0.3 U) 10/12/2022 12:40:29.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 4000 (0.4 U) BOLUSAMOUNTDELIVERED: 4000 (0.4 U) 10/12/2022 12:46:49.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 81000 (8.1 U) BOLUSAMOUNTDELIVERED: 81000 (8.1 U) 10/12/2022 14:00:25.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 3000 (0.3 U) BOLUSAMOUNTDELIVERED: 3000 (0.3 U) 10/12/2022 15:05:43.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 9000 (0.9 U) BOLUSAMOUNTDELIVERED: 9000 (0.9 U) 10/12/2022 18:11:53.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 93000 (9.3 U) BOLUSAMOUNTDELIVERED: 93000 (9.3 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. 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 DURING THE TESTING. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/10/2022 16:58:00.000 LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/10/2022 07:42:00.000 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 SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA1 WAS INSTALLED IN A TEST PCBA2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT, SUSPECTED ON THE PCBA 2. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (24.0 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. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE OVER DELIVERY WAS NOT CONFIRMED. UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WAS CONFIRMED. UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, SUSPECTED ON THE 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.
(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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 780G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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.
DEVICE WAS RETURNED FOR ANALYSIS.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE VENT. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 50 MG/DL TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER ALLEGED INSULIN PUMP WAS OVER DELIVERING BECAUSE NOTHING CHANGED IN THE SETTING. CUSTOMER REPORTS THEY WERE UNSURE IF THE PROGRAMMING WAS ACCURATE. CUSTOMER WAS UNABLE TO UPLOAD TO CARELINK. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2853852 | MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1886 | HG6DZKZZZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |