MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
Report
- Report Number
- 2032227-2024-201828
- Event Type
- Death
- Date Received
- July 12, 2024
- Date of Event
- September 23, 2023
- Report Date
- July 12, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000456634
- Removal / Correction Number
- 2032227-060322-002-C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. THE CUSTOMER PASSED AWAY (DUE TO CANCER) ON (B)(6) 2023. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP/MOBILE (BLUETOOTH) COMMUNICATION ANOMALY FOUND ON 01-JUN-2022. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR 41 AND PUMP ERROR 43 ALARM FOUND ON 10-JUN-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 0.08745 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. THE PUMP PROPERLY PAIRED TO MINIMED MOBILE APP ON A SAMSUNG GALAXY S21 PHONE AND APPLE IPHONE 12. NO PUMP/MOBILE (BLUETOOTH) COMMUNICATION ANOMALY NOTED. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 01-JUN-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 01-JUN-2022 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 06/01/2022 11:50:09.000. DAILYTOTALOFALLINSULINDELIVERED: 327250 (32.725 U). DAILYTOTALOFBASALINSULINDELIVERED: 193750 (19.375 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 133500 (13.35 U). 06/01/2022 11:55:57.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 31000 (3.1 U), BOLUSAMOUNTDELIVERED: 31000 (3.1 U). 06/01/2022 14:36:39.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 102500 (10.25 U), BOLUSAMOUNTDELIVERED: 102500 (10.25 U). IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 10-JUN-2022, PUMP ERROR 41 ALARM AND PUMP ERROR 43 ALARM NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 10-JUN-2022 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 06/10/2022 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 530750 (53.075 U). DAILYTOTALOFBASALINSULINDELIVERED: 357250 (35.725 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 173500 (17.35 U). 06/10/2022 08:30:37.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 26500 (2.65 U), BOLUSAMOUNTDELIVERED: 26500 (2.65 U). 06/10/2022 16:55:15.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 147000 (14.7 U), BOLUSAMOUNTDELIVERED: 147000 (14.7 U). PUMP ERROR 43 ALARM (FILENUMBER 121 LINENUMBER 589) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/31/2022 05:05:03.000. PUMP ERROR 41 ALARM (FILENUMBER 121 LINENUMBER 713) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 06/10/2022 09:33:00.000. PUMP ERROR 43 ALARM (FILENUMBER 121 LINENUMBER 589) AND PUMP ERROR 41 ALARM (FILENUMBER 121 LINENUMBER 713) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE (PRIMARY) EVENT DATE OF 23-SEP-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE (PRIMARY) EVENT DATE OF 23-SEP-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 09/23/2023 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U). DAILYTOTALOFBASALINSULINDELIVERED: 0 (0 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 0 (0 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. THERE WERE NO OTHER UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 10-JUN-2022 IN THE FORMATTED HISTORY FILE. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 01-JUN-2022 AND (PRIMARY) EVENT DATE 23-SEP-2023 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/21/2023 07:55:34.000, 09/21/2023 08:01:50.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/30/2022 18:52:00.000 09/21/2023 08:01:50.000 REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/31/2022 04:23:00.000, 05/31/2022 04:33:00.000, 09/21/2023 07:40:00.000, 09/21/2023 07:50:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/31/2022 05:05:16.000, 05/31/2022 05:05:24.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/31/2022 04:54:00.000, 05/31/2022 05:04:00.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/31/2022 05:05:03.000. 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. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 23-SEP-2023 AT 4:47:00 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 30-MAY-2022, 31-MAY-2022 AND 21-SEP-2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND PUMP ERROR 23 ALARM. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND PUMP ERROR 23 ALARM NOTED DURING TESTING. 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. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.04 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. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP WITH A LOOSE METAL CONTACT DUE TO A BROKEN THREE HEAT STAKE POST. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE 23-SEP-2023 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. 09/14/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 102750 (10.275 U). 09/15/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 257500 (25.75 U). 09/16/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 303250 (30.325 U). 09/17/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 323750 (32.375 U). 09/18/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 173250 (17.325 U). 09/19/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 254000 (25.4 U). 09/20/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 323000 (32.3 U). 09/21/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 150500 (15.05 U). 09/22/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U). 09/23/2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U). THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR PUMP/MOBILE (BLUETOOTH) COMMUNICATION ANOMALY WAS NOT CONFIRMED. BATTERY CAP CONTACT MISSING/DAMAGED WAS CONFIRMED. ALSO, PUMP ERROR 43 ALARM (FILENUMBER 121 LINENUMBER 589) AND PUMP ERROR 41 ALARM (FILENUMBER 121 LINENUMBER 713) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. 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. THE CUSTOMER DID NOT WEAR THE INSULIN PUMP AT THE TIME OF THE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1881. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1881 WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316035 | MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1881 | 000000763000456634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Unknown | Death | FRN-UNK-RSVR, UNOMED INF SET |