PUMP MMT-1780KPK 670G PATHWAY BLACK MG
Report
- Report Number
- 2032227-2022-344922
- Event Type
- Malfunction
- Date Received
- October 4, 2022
- Date of Event
- September 22, 2022
- Report Date
- May 21, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000190460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF TEST. THE PUMP POWERED UP PROPERLY AFTER THE TEST BATTERY WAS INSTALLED. THE PUMP WAS PROGRAMMED AND MONITORED FOR 3 DAYS. NO BLANK DISPLAY NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. THE PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, AND CRACKED CASE AT CORNER OF THE BELT CLIP RAIL. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND PARTIALLY DETACHED RETAINER. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 22-SEP-2022 IN THE PUMP HISTORY FILE. 09/16/2022 04:45:10.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104). 09/16/2022 04:48:12.000 BATTERYREMOVED. 09/16/2022 04:48:12.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/16/2022 04:48:55.000 BATTERYREMOVED. 09/16/2022 04:49:04.000 BATTERYINSERTED. 09/21/2022 05:36:14.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61). 09/21/2022 05:46:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61). 09/21/2022 12:33:43.000 BATTERYREMOVED. 09/21/2022 12:33:43.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:33:56.000 BATTERYINSERTED. 09/21/2022 12:33:57.000 BATTERYREMOVED. 09/21/2022 12:33:57.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:34:03.000 BATTERYINSERTED. 09/21/2022 12:34:03.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:34:14.000 BATTERYREMOVED. 09/21/2022 12:34:14.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:34:18.000 BATTERYREMOVED. 09/21/2022 12:34:22.000 BATTERYINSERTED. 09/21/2022 12:34:23.000 BATTERYREMOVED. 09/21/2022 12:34:23.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:34:27.000 BATTERYINSERTED. 09/21/2022 12:35:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104). 09/21/2022 12:35:24.000 BATTERYREMOVED. 09/21/2022 12:35:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:35:26.000 BATTERYINSERTED. 09/21/2022 12:35:27.000 BATTERYREMOVED. 09/21/2022 12:35:27.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:35:33.000 BATTERYINSERTED. 09/21/2022 12:35:33.000 BATTERYREMOVED. 09/21/2022 12:35:33.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:35:43.000 BATTERYINSERTED. 09/21/2022 12:35:43.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:35:47.000 BATTERYREMOVED. 09/21/2022 12:35:47.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:35:53.000 BATTERYINSERTED. 09/21/2022 12:36:00.000 BATTERYREMOVED. 09/21/2022 12:36:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:36:04.000 BATTERYINSERTED. 09/21/2022 12:36:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:36:09.000 BATTERYREMOVED. 09/21/2022 12:36:09.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:36:15.000 BATTERYINSERTED. 09/21/2022 12:36:15.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:36:15.000 BATTERYREMOVED. 09/21/2022 12:36:15.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:36:20.000 BATTERYINSERTED. 09/21/2022 12:36:28.000 BATTERYREMOVED. 09/21/2022 12:36:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:36:32.000 BATTERYREMOVED. 09/21/2022 12:36:34.000 BATTERYREMOVED. 09/21/2022 12:36:40.000 BATTERYREMOVED. 09/21/2022 12:37:01.000 BATTERYREMOVED. 09/21/2022 12:37:09.000 BATTERYREMOVED. 09/21/2022 12:37:13.000 BATTERYREMOVED. 09/21/2022 12:37:20.000 BATTERYINSERTED. 09/21/2022 12:37:21.000 BATTERYREMOVED. 09/21/2022 12:37:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:37:58.000 BATTERYINSERTED. 09/21/2022 12:37:58.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:38:04.000 BATTERYREMOVED. 09/21/2022 12:38:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:38:25.000 BATTERYINSERTED. 09/21/2022 12:38:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:38:25.000 BATTERYREMOVED. 09/21/2022 12:38:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:38:55.000 BATTERYREMOVED. 09/21/2022 12:38:58.000 BATTERYINSERTED. 09/21/2022 12:38:58.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:38:59.000 BATTERYREMOVED. 09/21/2022 12:38:59.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:39:08.000 BATTERYINSERTED. 09/21/2022 12:39:08.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:39:15.000 BATTERYREMOVED. 09/21/2022 12:39:15.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:39:19.000 BATTERYINSERTED. 09/21/2022 12:39:19.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:39:19.000 BATTERYREMOVED. 09/21/2022 12:39:19.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:39:24.000 BATTERYREMOVED. 09/21/2022 12:39:51.000 BATTERYINSERTED. 09/21/2022 12:39:51.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:40:01.000 BATTERYREMOVED. 09/21/2022 12:40:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:40:05.000 BATTERYREMOVED. 09/21/2022 12:40:24.000 BATTERYINSERTED. 09/21/2022 12:40:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:40:26.000 BATTERYREMOVED. 09/21/2022 12:40:26.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:40:30.000 BATTERYREMOVED. 09/21/2022 12:40:34.000 BATTERYINSERTED. 09/21/2022 12:40:34.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:41:02.000 BATTERYREMOVED. 09/21/2022 12:41:02.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:41:34.000 BATTERYINSERTED. 09/21/2022 12:41:44.000 BATTERYREMOVED. 09/21/2022 12:41:44.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:42:25.000 BATTERYINSERTED. 09/21/2022 12:42:28.000 BATTERYREMOVED. 09/21/2022 12:42:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:42:32.000 BATTERYINSERTED. 09/21/2022 12:42:32.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 12:42:35.000 BATTERYREMOVED. 09/21/2022 12:42:35.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 12:42:38.000 BATTERYINSERTED. 09/21/2022 15:17:00.000 BATTERYREMOVED. 09/21/2022 15:17:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 15:17:04.000 BATTERYINSERTED. 09/21/2022 15:17:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 15:27:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 15:28:46.000 BATTERYREMOVED. 09/21/2022 15:28:46.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 15:28:49.000 BATTERYINSERTED. 09/21/2022 15:28:52.000 BATTERYREMOVED. 09/21/2022 15:28:52.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 15:28:56.000 BATTERYINSERTED. 09/21/2022 15:28:56.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58). 09/21/2022 15:29:00.000 BATTERYREMOVED. 09/21/2022 15:29:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 15:29:07.000 BATTERYINSERTED. 09/21/2022 15:29:07.000 BATTERYREMOVED. 09/21/2022 15:29:07.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 15:29:13.000 BATTERYREMOVED. 09/21/2022 15:39:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84). 09/21/2022 15:40:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23). 09/21/2022 15:40:17.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6). 09/21/2022 15:40:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6). LOW BATTERY ALERT WAS DUE TO THE BATTERY IN THE PUMP IS LOW ON POWER. NO STUCK KEY ALARM OR UNRESPONSIVE BUTTONS NOTED. NO DAMAGE NOTED ON THE KEYPAD TRACES. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. THE TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATTERY TEST ALARM NOTED. PUMP ERROR 23 AND BATTERY OUT LIMIT ALARM WERE DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES PUMP OR RESET DUE TO BATTERY BACKUP DEPLETION. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. 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. LOW BATTERY ALERT (104) NOT CONFIRMED. STUCK KEY ALARM (61) NOT CONFIRMED. FAILED BATT TEST (58) NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. BATT OUT LIMIT (6) NOT CONFIRMED. BLANK DISPLAY WAS NOT OBSERVED DURING ANALYSIS AND PASSED ALL REQUIRED TESTING. BLANK DISPLAY NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT BACK OF THE PUMP. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(4). 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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP NO LONGER FUNCTIONING. CUSTOMER STATED THAT DAMAGE ON THE RIGHT SIDE OF BATTERY HOUSING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WILL DISCONTINUE THE USE OF INSULIN PUMP AND IT WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1589091 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG31T19 | 000000763000190460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male |