MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2024-245666
- Event Type
- Injury
- Date Received
- September 27, 2024
- Date of Event
- September 8, 2024
- Report Date
- November 26, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
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 0.0874 INCHES. REVIEWED THE PUMP HISTORY FILE AND FOUND PUMP ERROR 43 ON (B)(6)2024 07:18:00.000 (LINENUMBER: 600, FILENUMBER: 121) FOLLOWED BY PUMP ERROR 41 ON (B)(6)2024 07:18:00.000 (LINENUMBER: 724, FILENUMBER: 121). [PER FREGER, MARK ¿ R&D ENGINEER THE DETAILED TRACES DO NOT COVER THE TIME FRAME OF THE PE41 AND PE43. AS PER FILENUMBER/LINENUMBER, PUMP ERROR 43 (FILENUM/LINENUM=121/600) WAS GENERATED DUE TO MOTOR POWER REQUEST TIMEOUT - SUSPECTING THE HW PUMP ERROR 41 (FILENUM/LINENUM=121/724) WAS GENERATED SINCE MOTOR APPLICATION REGISTERED VOLTAGE FAILURE. MEASURED VOLTAGE WAS BELOW THRESHOLD.] PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.0 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. PUMP ERROR 43 AND PUMP ERROR 41 WERE ISOLATED TO THE ELECTRONIC ASSEMBLY AND THE MOTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW PERTAINING TO SVN (B)(4) AND EVENT DATE 08-SEP-2024. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE 08-SEP-2024 IN THE PUMP HISTORY FILE. (B)(6)2024 00:43:43.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U) (B)(6)2024 00:48:51.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1750 (0.175 U) BOLUSAMOUNTDELIVERED: 1750 (0.175 U) (B)(6)2024 00:53:51.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6)2024 00:58:49.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1750 (0.175 U) BOLUSAMOUNTDELIVERED: 1750 (0.175 U) (B)(6)2024 01:03:49.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6)2024 01:08:51.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1750 (0.175 U) BOLUSAMOUNTDELIVERED: 1750 (0.175 U) (B)(6)2024 01:13:57.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9) NORMALBOLUSAMOUNTPROGRAMMED: 4000 (0.4 U) BOLUSAMOUNTDELIVERED: 4000 (0.4 U) (B)(6)2024 01:18:49.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6)2024 01:23:49.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1750 (0.175 U) BOLUSAMOUNTDELIVERED: 1750 (0.175 U) (B)(6)2024 01:28:47.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) UNABLE TO VERIFY CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE OF 08-SEP-2024 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. THERE WERE NO AUTOSUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE USERSUSPENDED (2) ALARM NOTED ON THE EVENT DATE 08-SEP-2024 IN THE PUMP HISTORY FILE. (B)(6)2024 15:09:43.000 INSULINDELIVERYSTOPPED (30) REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) (B)(6)2024 16:44:31.000 INSULINDELIVERYSTOPPED (30) REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 08-SEP-2024 IN THE PUMP HISTORY FILE. (B)(6)2024 19:17:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6)2024 19:36:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR2ALERT (781) (B)(6)2024 12:47:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) (B)(6)2024 22:18:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: CHANGEBATTERYFAULT (73) (B)(6)2024 22:18:50.000 BATTERYREMOVED (55) (B)(6)2024 22:18:50.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 22:19:07.000 BATTERYINSERTED (44) THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. LOW BATTERY ALERT WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. THE REPLACE BATTERY ALERT/ CHANGE BATTERY FAULT (73) WAS EXPECTED (TRIGGERED 9.5 HOURS AFTER THE LOW BATTERY ALERT). 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 240 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALERT NOTED. LOSTSENSOR1ALERT (780) - NOT CONFIRMED. LOWBATTERYALERT (104) - NOT CONFIRMED. CHANGEBATTERYFAULT (73) - NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS. PUMP ERROR 43 AND PUMP ERROR 41 WERE ISOLATED TO THE ELECTRONIC ASSEMBLY AND THE MOTOR. PUMP ERROR 43 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 41 CONFIRMED IN THE PUMP HISTORY FILE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED SUMMARY: CUSTOMER STOPPED USING THE PUMP AT 4PM AND WENT TO THE EMERGENCY ROOM AT 11PM FOR A LOW OF 56MG/DL. THE LOWS STARTED AT 10:30AM. CUSTOMER DECLINED FURTHER TROUBLESHOOTING AT THE END. CUSTOMER DISCONTINUED THE PUMP AND RETURNED THE PUMP FOR ANALYSIS.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 56 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH EMS/AMBULANCE/ER VISIT. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-242A, MMT-1884, MMT-332A. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. ALSO, THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BG EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-242A. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1709010 | MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1884 | NG3652791H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Female | Required Intervention | FRN-MMT-332A-RSVR, UNOMED INF SET. |