MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2024-247249
- Event Type
- Injury
- Date Received
- October 1, 2024
- Date of Event
- September 11, 2024
- Report Date
- October 25, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. 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 0.08720 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM ON (B)(6) 2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATES OF 02-MAY-2023, 01-AUG-2023 AND 11-SEP-2024. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE CUSTOMER'S EVENT DATE OF 02-SEP-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE CUSTOMER'S EVENT DATE 02-SEP-2024 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. 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. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERROR(S)/ALARM(S) 1 WEEK PRIOR TO THE EVENT DATES OF 02-MAY-2023 AND 01-AUG-2023 IN THE FORMATTED HISTORY FILE. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE SS EVENT DATE 11-SEP-2024 AND CUSTOMER'S EVENT DATE 02-SEP-2024 IN THE FORMATTED HISTORY FILE. SENSOR ERROR ALERT (801) WAS FOUND ON: (B)(6) 2024 00:12:31.000, ON (B)(6) 2024 00:22:00.000. SG CALIBRATION ERROR (776) WAS FOUND ON: (B)(6) 2024 14:09:56.000, ON (B)(6) 2024 15:58:45.000. 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 WARMUP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR ERROR ALERT, SG CALIBRATION ERROR OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE 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. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2024 18:56:00.000. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 08:19:41.000, ON (B)(6) 2024 08:29:00.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2024 04:27:00.000, ON (B)(6) 2024 04:37:00.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2024 04:58:00.000, ON (B)(6) 2024 05:08:00.000. PUMP ERROR 68 ALARM WAS FOUND ON: (B)(6) 2024 05:09:06.000. PUMP ERROR 49 ALARM WAS FOUND ON: (B)(6) 2024 05:09:06.000, ON (B)(6) 2024 05:14:39.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2024 12:22:37.000, ON (B)(6) 2024 08:30:04.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2024 12:23:02.000, ON (B)(6) 2024 12:23:10.000, ON (B)(6) 2024 08:30:17.000, ON (B)(6) 2024 08:30:25.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER HAD USED A LOW POWER BATTERY. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.62 MV). THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP AND BATTERY CAP CONTACT MISSING/DAMAGED 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 SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. CUSTOMER ALLEGED FOR BATTERY CAP CONTACT MISSING/DAMAGED AND BLANK DISPLAY WERE NOT CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/LOW BGS AND DKA. 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 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 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.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED BLANK DISPLAY. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 1000 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, HYPERGLYCEMIA, HYPERGLYCEMIA TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), DISCONTINUE USE OF INSULIN DELIVERY SYSTEM, HOSPITALIZATION: OVERNIGHT STAY. CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: NOTHING MENTION IN THE HOSPITAL PATIENT SAID DOCUMENT TREATMENT FOR HIGH BG: HOSPITALIZE FOR OVER A WEEK. OTHER THAN INSULIN, INDICATE MEDICATIONS TAKEN TO TREAT DIABETES: IV DRIP DOCUMENT TYPE OF DIABETES: TYPE 1. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-396A, MMT-1884. CUSTOMER HAS NOT BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE PUMP AUTO MODE/SMART GUARD FEATURE WAS ACTIVE AT TIME OF HIGH BLOOD GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-396A. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38928 | 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 | NG3173128H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention| H| O |