MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2024-184219
- Event Type
- Malfunction
- Date Received
- June 10, 2024
- Date of Event
- May 20, 2024
- Report Date
- July 24, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- P160017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
THE PUMP WAS RECEIVED WITH BROKEN BATTERY TUBE THREADS, CRACKED/BROKEN OFF CASE AT THE BATTERY TUBE SIDE, AND CRACKED CASE AT CORNER OF THE BELT CLIP RAIL. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATTERY TEST ALARM NOTED. THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND DISPLACEMENT TEST. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 20-MAY-2024 IN THE PUMP HISTORY FILE. (B)(6)2024 08:02:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. (B)(6)2024 08:02:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL (B)(6)2024 11:17:30.000 BATTERYREMOVED (55) (B)(6)2024 11:17:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:17:31.000 BATTERYINSERTED (44) (B)(6)2024 11:17:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:17:50.000 BATTERYREMOVED (55) (B)(6)2024 11:17:50.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:17:51.000 BATTERYINSERTED (44) (B)(6)2024 11:17:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:17:52.000 BATTERYREMOVED (55) (B)(6)2024 11:17:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:17:55.000 BATTERYINSERTED (44) (B)(6)2024 11:17:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:17:56.000 BATTERYREMOVED (55) (B)(6)2024 11:17:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:06.000 BATTERYINSERTED (44) (B)(6)2024 11:18:06.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:08.000 BATTERYREMOVED (55) (B)(6)2024 11:18:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:21.000 BATTERYINSERTED (44) (B)(6)2024 11:18:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:22.000 BATTERYREMOVED (55) (B)(6)2024 11:18:22.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)/2024 11:18:22.000 BATTERYINSERTED (44) (B)(6)2024 11:18:22.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:25.000 BATTERYREMOVED (55) (B)(6)2024 11:18:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:27.000 BATTERYINSERTED (44) (B)(6)2024 11:18:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:28.000 BATTERYREMOVED (55) (B)(6)2024 11:18:28.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:30.000 BATTERYINSERTED (44) (B)(6)2024 11:18:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:32.000 BATTERYREMOVED (55) (B)(6)2024 11:18:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:33.000 BATTERYINSERTED (44) (B)(6)2024 11:18:33.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:39.000 BATTERYINSERTED (44) (B)(6)2024 11:18:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:39.000 BATTERYREMOVED (55) (B)(6)2024 11:18:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:43.000 BATTERYREMOVED (55) (B)(6)2024 11:18:44.000 BATTERYINSERTED (44) (B)(6)2024 11:18:44.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:45.000 BATTERYREMOVED (55) (B)(6)2024 11:18:45.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:18:51.000 BATTERYINSERTED (44) (B)(6)2024 11:18:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:18:52.000 BATTERYREMOVED (55) (B)(6)2024 11:18:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:19:04.000 BATTERYINSERTED (44) (B)(6)2024 11:19:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:19:06.000 BATTERYREMOVED (55) (B)(6)2024 11:19:06.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:19:15.000 BATTERYINSERTED (44) (B)(6)2024 11:19:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:19:16.000 BATTERYREMOVED (55) (B)(6)2024 11:19:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:19:21.000 BATTERYINSERTED (44) (B)(6)2024 11:19:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:19:22.000 BATTERYREMOVED (55) (B)(6)2024 11:19:22.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:19:26.000 BATTERYINSERTED (44) (B)(6)2024 11:19:26.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:19:31.000 BATTERYREMOVED (55) (B)(6)2024 11:19:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:19:31.000 BATTERYINSERTED (44) (B)(6)2024 11:19:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:19:37.000 BATTERYREMOVED (55) (B)(6)2024 11:19:37.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:19:49.000 BATTERYINSERTED (44) (B)(6)2024 11:19:49.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:19:50.000 BATTERYREMOVED (55) (B)(6)2024 11:19:50.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:22:45.000 BATTERYINSERTED (44) (B)(6)2024 11:22:45.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:22:46.000 BATTERYREMOVED (55) (B)(6)2024 11:22:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:24:23.000 BATTERYINSERTED (44) (B)(6)2024 11:24:23.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:24:24.000 BATTERYREMOVED (55) (B)(6)2024 11:24:24.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:24:28.000 BATTERYINSERTED (44) (B)(6)2024 11:24:28.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:24:29.000 BATTERYREMOVED (55) (B)(6)2024 11:24:29.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:34:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:34:04.000 BATTERYINSERTED (44) (B)(6)2024 11:34:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:34:06.000 BATTERYREMOVED (55) (B)(6)2024 11:34:06.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:36:52.000 BATTERYINSERTED (44) (B)(6)2024 11:36:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:36:53.000 BATTERYREMOVED (55) (B)(6)2024 11:36:53.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:37:13.000 BATTERYINSERTED (44) (B)(6)2024 11:37:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:37:14.000 BATTERYREMOVED (55) (B)(6)2024 11:37:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:37:18.000 BATTERYINSERTED (44) (B)(6)2024 11:37:18.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:37:20.000 BATTERYREMOVED (55) (B)(6)2024 11:37:20.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:37:27.000 BATTERYINSERTED (44) (B)(6)2024 11:37:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:37:37.000 BATTERYREMOVED (55) (B)(6)2024 11:37:37.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:37:44.000 BATTERYINSERTED (44) (B)(6)2024 11:37:44.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 11:37:53.000 BATTERYREMOVED (55) (B)(6)/2024 11:37:53.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 11:47:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:52:03.000 BATTERYREMOVED (55) (B)(6)2024 12:52:03.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:52:29.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: SEVERELOW (827) (B)(6)2024 12:52:42.000 BATTERYINSERTED (44) (B)(6)2024 12:52:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 12:51:27.000 BATTERYREMOVED (55) (B)(6)2024 12:51:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:51:34.000 BATTERYREMOVED (55) (B)(6)2024 12:51:41.000 BATTERYINSERTED (44) (B)(6)2024 12:51:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 12:51:42.000 BATTERYREMOVED (55) (B)(6)2024 12:51:42.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:51:45.000 BATTERYREMOVED (55) (B)(6)2024 12:51:49.000 BATTERYREMOVED (55) (B)(6)2024 12:51:52.000 BATTERYREMOVED (55) (B)(6)2024 12:52:01.000 BATTERYINSERTED (44) (B)(6)2024 12:52:01.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 12:52:02.000 BATTERYREMOVED (55) (B)(6) 2024 12:52:02.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:52:09.000 BATTERYREMOVED (55) (B)(6)2024 12:52:13.000 BATTERYINSERTED (44) (B)(6)2024 12:52:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 12:52:13.000 BATTERYREMOVED (55) (B)(6)2024 12:52:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:52:22.000 BATTERYINSERTED (44) (B)(6)2024 12:52:32.000 BATTERYREMOVED (55) (B)(6)2024 12:52:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:52:36.000 BATTERYINSERTED (44) (B)(6)2024 12:52:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 12:54:11.000 BATTERYREMOVED (55) (B)(6)2024 12:54:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 12:54:15.000 BATTERYINSERTED (44) (B)(6)2024 13:04:11.000 BATTERYREMOVED (55) (B)(6)2024 13:04:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:04:25.000 BATTERYINSERTED (44) (B)(6)2024 13:08:15.000 BATTERYREMOVED (55) (B)(6)2024 13:08:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:08:25.000 BATTERYINSERTED (44) (B)(6)2024 13:08:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 13:08:28.000 BATTERYREMOVED (55) (B)(6)2024 13:08:28.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:09:09.000 BATTERYREMOVED (55) (B)(6)2024 13:09:15.000 BATTERYINSERTED (44) (B)(6)2024 13:09:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 13:09:31.000 BATTERYREMOVED (55) (B)(6)2024 13:09:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:09:38.000 BATTERYINSERTED (44) (B)(6)2024 13:09:38.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 13:10:30.000 BATTERYREMOVED (55) (B)(6)2024 13:10:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:10:33.000 BATTERYINSERTED (44) (B)(6)2024 13:10:54.000 BATTERYREMOVED (55) (B)(6)2024 13:10:54.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:10:58.000 BATTERYINSERTED (44) (B)(6)2024 13:10:58.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 13:11:07.000 BATTERYREMOVED (55) (B)(6)2024 13:11:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:11:14.000 BATTERYINSERTED (44) (B)(6)2024 13:11:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6)2024 13:11:14.000 BATTERYREMOVED (55) (B)(6)2024 13:11:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:11:17.000 BATTERYINSERTED (44) (B)(6)2024 13:11:21.000 BATTERYREMOVED (55) (B)(6)2024 13:11:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:11:26.000 BATTERYINSERTED (44) (B)(6)2024 13:11:36.000 BATTERYREMOVED (55) (B)(6)2024 13:11:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:11:55.000 BATTERYINSERTED (44) (B)(6)2024 13:11:56.000 BATTERYREMOVED (55) (B)(6)2024 13:11:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:12:01.000 BATTERYINSERTED (44) (B)(6)2024 13:12:04.000 BATTERYREMOVED (55) (B)(6)2024 13:12:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:12:15.000 BATTERYINSERTED (44) (B)(6)2024 13:12:51.000 BATTERYREMOVED (55) (B)(6)2024 13:12:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:13:40.000 BATTERYREMOVED (55) (B)(6)2024 13:13:46.000 BATTERYINSERTED (44) (B)(6)2024 13:14:25.000 BATTERYREMOVED (55) (B)(6)2024 13:14:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:14:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6)2024 13:15:24.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 13:15:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 13:16:22.000 BATTERYREMOVED (55) (B)(6)2024 13:16:22.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)/2024 13:16:26.000 BATTERYREMOVED (55) (B)(6)/2024 13:16:30.000 BATTERYREMOVED (55) (B)(6)2024 13:16:42.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6)2024 13:16:49.000 BATTERYREMOVED (55) (B)(6)2024 13:16:49.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:17:01.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 13:17:09.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 13:17:36.000 BATTERYREMOVED (55) (B)(6)2024 13:17:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:17:41.000 BATTERYINSERTED (44) (B)(6)2024 13:25:20.000 BATTERYREMOVED (55) (B)(6)2024 13:25:20.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:25:32.000 BATTERYINSERTED (44) (B)(6)2024 13:25:34.000 BATTERYREMOVED (55) (B)(6)2024 13:25:34.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:25:37.000 BATTERYINSERTED (44) (B)(6)2024 13:25:39.000 BATTERYREMOVED (55) (B)(6)2024 13:25:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:25:42.000 BATTERYINSERTED (44) (B)(6)2024 13:25:46.000 BATTERYREMOVED (55) (B)(6)2024 13:25:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:25:50.000 BATTERYINSERTED (44) (B)(6)2024 13:25:56.000 BATTERYREMOVED (55) (B)(6)/2024 13:25:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:27:11.000 BATTERYREMOVED (55) (B)(6)2024 13:28:09.000 BATTERYINSERTED (44) (B)(6)2024 13:28:17.000 BATTERYREMOVED (55) (B)(6)2024 13:28:17.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:28:26.000 BATTERYINSERTED (44) (B)(6)2024 13:28:51.000 BATTERYREMOVED (55) (B)(6)2024 13:28:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:28:59.000 BATTERYREMOVED (55) (B)(6)2024 13:30:08.000 BATTERYREMOVED (55) (B)(6)2024 13:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:38:08.000 BATTERYREMOVED (55) (B)(6)2024 13:38:15.000 BATTERYREMOVED (55) (B)(6)2024 13:38:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6)2024 13:39:00.000 BATTERYREMOVED (55) (B)(6)2024 13:39:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:39:08.000 BATTERYREMOVED (55) (B)(6)2024 13:39:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:39:23.000 BATTERYREMOVED (55) (B)(6)2024 13:39:26.000 BATTERYREMOVED (55) (B)(6)2024 13:39:34.000 BATTERYINSERTED (44) (B)(6)2024 13:39:42.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 13:45:29.000 BATTERYREMOVED (55) (B)(6)2024 13:45:29.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)/2024 13:45:31.000 BATTERYINSERTED (44) (B)(6)2024 13:45:58.000 BATTERYREMOVED (55) (B)(6)2024 13:45:59.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:46:05.000 BATTERYINSERTED (44) (B)(6)2024 13:46:05.000 BATTERYREMOVED (55) (B)(6)/2024 13:46:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:46:10.000 BATTERYINSERTED (44) (B)(6)2024 13:58:56.000 BATTERYREMOVED (55) (B)(6)2024 13:58:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:58:59.000 BATTERYINSERTED (44) (B)(6)2024 13:59:04.000 BATTERYREMOVED (55) (B)(6)2024 13:59:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 13:59:08.000 BATTERYINSERTED (44) (B)(6)2024 14:01:36.000 BATTERYREMOVED (55) (B)(6)2024 14:01:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:01:41.000 BATTERYINSERTED (44) (B)(6)2024 14:01:56.000 BATTERYREMOVED (55) (B)(6)2024 14:01:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:01:58.000 BATTERYINSERTED (44) (B)(6)2024 14:02:37.000 BATTERYREMOVED (55) (B)(6)2024 14:02:37.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:02:40.000 BATTERYINSERTED (44) (B)(6)2024 14:02:41.000 BATTERYREMOVED (55) (B)(6)2024 14:02:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:02:46.000 BATTERYINSERTED (44) (B)(6)2024 14:02:47.000 BATTERYREMOVED (55) (B)(6)2024 14:02:47.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:02:51.000 BATTERYINSERTED (44) (B)(6)2024 14:02:53.000 BATTERYREMOVED (55) (B)(6)2024 14:02:53.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:02:56.000 BATTERYINSERTED (44) (B)(6)2024 14:03:51.000 BATTERYREMOVED (55) (B)(6)2024 14:03:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:04:44.000 BATTERYINSERTED (44) (B)(6)2024 14:04:51.000 BATTERYREMOVED (55) (B)(6)2024 14:04:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:04:54.000 BATTERYINSERTED (44) (B)(6)2024 14:04:56.000 BATTERYREMOVED (55) (B)(6)2024 14:04:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:05:01.000 BATTERYINSERTED (44) (B)(6)2024 14:05:18.000 BATTERYREMOVED (55) (B)(6)2024 14:05:18.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:05:24.000 BATTERYINSERTED (44) (B)(6)2024 14:05:25.000 BATTERYREMOVED (55) (B)(6)2024 14:05:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:05:31.000 BATTERYINSERTED (44) (B)(6)2024 14:05:52.000 BATTERYREMOVED (55) (B)(6)2024 14:05:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:05:58.000 BATTERYINSERTED (44) (B)(6)2024 14:06:07.000 BATTERYREMOVED (55) (B)(6)2024 14:06:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:06:10.000 BATTERYINSERTED (44) (B)(6)2024 14:06:12.000 BATTERYREMOVED (55) (B)(6)2024 14:06:12.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:06:29.000 BATTERYREMOVED (55) (B)(6)2024 14:06:59.000 BATTERYINSERTED (44) (B)(6)2024 14:08:08.000 BATTERYREMOVED (55) (B)(6)2024 14:08:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)/2024 14:08:11.000 BATTERYREMOVED (55) (B)(6)2024 14:08:18.000 BATTERYREMOVED (55) (B)(6)2024 14:08:35.000 BATTERYINSERTED (44) (B)(6)2024 14:08:53.000 BATTERYREMOVED (55) (B)(6)2024 14:08:53.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:08:56.000 BATTERYREMOVED (55) (B)(6)2024 14:09:00.000 BATTERYREMOVED (55) (B)(6)2024 14:09:08.000 BATTERYINSERTED (44) (B)(6)2024 14:09:19.000 BATTERYREMOVED (55) (B)(6)2024 14:09:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:09:26.000 BATTERYREMOVED (55) (B)(6)2024 14:19:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:20:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6)2024 14:20:18.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 14:20:26.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 14:21:13.000 BATTERYREMOVED (55) (B)(6)2024 14:21:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:21:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6)2024 14:21:33.000 BATTERYREMOVED (55) (B)(6)2024 14:21:33.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6)2024 14:21:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6)2024 14:22:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 14:22:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6)2024 09:24:54.000 BATTERYREMOVED (55) (B)(6)2024 09:24:54.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. PUMP ERROR 23 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES AND THE PUMP RESET. NODELIVERY (7) ALARM - NOT CONFIRMED. FAILEDBATTTEST (58) - NOT CONFIRMED. PUMP ERROR 23 - NOT CONFIRMED. BATTOUTLIMIT (6) - NOT CONFIRMED. 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. COSMETIC DAMAGE WAS CONFIRMED AT THE BACK OF THE PUMP EXTENDING TOWARDS THE SIDE OF THE PUMP. FAILED BATT TEST NOT CONFIRMED. 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. 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 RECEIVED A BATTERY-FAILED ALARM AND A LONG CRACK ON THE PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT NO DAMAGE WAS REPORTED ON BATTERY CAP CONTACTS OR BATTERY COMPARTMENTS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173118 | 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 | HG5K4NWZZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female |