MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2024-160854
- Event Type
- Death
- Date Received
- April 30, 2024
- Date of Event
- March 10, 2024
- Report Date
- April 29, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000414344
- PMA / PMN Number
- P150001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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. ON (B)(4), SVN#: (B)(6) - CUSTOMER RETURNED PUMP FOR AN ALLEGED BATTERY CAP CONTACT MISSING/DAMAGED FOUND ON (B)(6) 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(B)(4). HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. THE PUMP WAS MONITORED FOR SEVERAL DAYS WITH A NEW TEST AA 1.5V BATTERY TO ENABLE THE PUMP TO CHARGE. A BATTERY SIMULATOR WAS USED AND CONTINUED TESTING. STILL, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 26-NOV-2022, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 26-NOV-2022 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2022 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 492250 (49.225 U) DAILYTOTALOFBASALINSULINDELIVERED: 214250 (21.425 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 278000 (27.8 U) (B)(6) 2022 08:49:39.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 120000 (12 U) BOLUSAMOUNTDELIVERED: 120000 (12 U) (B)(6) 2022 12:12:41.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 60000 (6 U) BOLUSAMOUNTDELIVERED: 60000 (6 U) (B)(6) 2022 18:04:45.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 98000 (9.8 U) BOLUSAMOUNTDELIVERED: 98000 (9.8 U) PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2021 TO (B)(6) 2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARMS/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATE OF 10-MAR-2024. 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. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 26-NOV-2022 AND 1 WEEK PRIOR SURROUNDING THE DATE OF (B)(6) 2024 LISTED IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2022 09:27:42.000 (B)(6)2022 09:29:11.000 (B)(6)2022 09:30:12.000 (B)(6)2022 09:30:32.000 (B)(6)2022 09:34:38.000 (B)(6)2022 09:39:43.000 (B)(6)2022 09:43:54.000 (B)(6)2022 09:47:24.000 (B)(6)2024 09:00:31.000 LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2022 08:41:00.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2022 09:28:50.000 (B)(6)2022 09:30:02.000 (B)(6)2022 09:30:26.000 (B)(6)2022 09:34:32.000 (B)(6)2022 09:39:36.000 (B)(6)2022 09:43:47.000 (B)(6)2022 09:47:16.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2024 09:00:46.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2024 09:00:58.000 (B)(6)2024 09:01:06.000 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING THE DETAILED TRACE FILE/DIAGNOSTIC TRACE FILE, PUMP ERROR 23 ALARM/POWER LOSS ALARM WERE EXPECTED. THE BEHAVIOR WAS EXPECTED SINCE THE USER REMOVED AA BATTERY AND PRESSED BACK KEY FOR > 8 SEC - THIS DISCONNECTS BACKUP BATTERY AND PUMP LOOSES POWER. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 02-MAR-2024 AT 8:42:59 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF 26-NOV-2022. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM. THE 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 PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN THE ORIGINAL PCBA 2, 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 AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS), SUSPECTED ON THE HW (PCBA 1/PCBA 2). FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.4 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 CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP OR MISSING/DAMAGED BATTERY CAP CONTACT NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE DATE OF (B)(6) 2024 LISTED ON PUMP HISTORY AND THE DAYS PRIOR TO THAT DATE. (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 472250 (47.225 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 481250 (48.125 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 444250 (44.425 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 488000 (48.8 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 516250 (51.625 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 487250 (48.725 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 528000 (52.8 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 501250 (50.125 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 440500 (44.05 U) (B)(6)2024 DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U) THERE IS NO AVAILABLE DATA AFTER (B)(6)2024. BATTERY CAP CONTACT MISSING/DAMAGED WAS NOT CONFIRMED. HOWEVER, AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED, SUSPECTED ON THE HW (PCBA 1/PCBA 2). 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 PASSED AWAY ON (B)(6) 2024. THE CUSTOMER WAS ADMITTED TO A HOSPITAL PRIOR TO THE REPORTED INCIDENT. THE CAUSE OF DEATH WAS COVID. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: HAD SYMPTOMS RELATED TO COVID. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE PUMP WAS NOT WORN AT THE TIME OF PASSING. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: MMT-386A, MMT-332A, MMT-1880. NO PRODUCT RETURN IS REQUIRED FOR MMT-386A, MMT-332A, OR THE PRODUCT MMT-1880 THAT WAS RETURNED FOR PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130796 | 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 | HG5JFUTZZ | 000000763000414344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Death | FRN-MMT-332-RSVR, UNOMED INF SET, MMT-UNK-SNSR. |