630G INSULIN PUMP MMT-1715KR 630G
Report
- Report Number
- 2032227-2023-285459
- Event Type
- Malfunction
- Date Received
- October 18, 2023
- Date of Event
- September 22, 2023
- Report Date
- November 29, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 000000763000367060
- PMA / PMN Number
- P150001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF TEST. 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. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. 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: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 22-SEP-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 13:57:37.000 BATTERYREMOVED (B)(6) 2023 13:57:37.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 14:01:07.000 BATTERYINSERTED (B)(6) 2023 14:01:07.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) (B)(6) 2023 14:01:08.000 BATTERYREMOVED (B)(6) 2023 14:01:08.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 14:03:35.000 BATTERYREMOVED (B)(6) 2023 14:04:14.000 BATTERYINSERTED (B)(6) 2023 14:04:14.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) (B)(6) 2023 14:04:15.000 BATTERYREMOVED (B)(6) 2023 14:04:15.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 14:14:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) (B)(6) 2023 17:01:46.000 BATTERYREMOVED (B)(6) 2023 17:01:46.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 17:01:46.000 BATTERYREMOVED (B)(6) 2023 17:01:46.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 17:11:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 17:12:03.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) (B)(6) 2023 17:12:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6) (B)(6) 2023 17:19:38.000 BATTERYREMOVED (B)(6) 2023 17:19:38.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 17:19:52.000 BATTERYREMOVED (B)(6) 2023 17:19:56.000 BATTERYREMOVED (B)(6) 2023 17:29:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:57:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) (B)(6) 2023 18:58:39.000 BATTERYREMOVED (B)(6) 2023 18:58:40.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:59:03.000 BATTERYINSERTED (B)(6) 2023 18:59:24.000 BATTERYREMOVED (B)(6) 2023 18:59:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:59:39.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) (B)(6) 2023 19:00:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) (B)(6) 2023 19:00:15.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) (B)(6) 2023 19:02:51.000 BATTERYREMOVED (B)(6) 2023 19:02:51.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 19:03:11.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) (B)(6) 2023 19:03:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) (B)(6) 2023 19:03:36.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. FAILED BATTERY TEST ALARM WAS 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 PUMP'S TIME RESET. FAILED BATT TEST (58) NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. BATT OUT LIMIT (6) NOT CONFIRMED. BLANK DISPLAY NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE 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.
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, 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 CUSTOMER MENTIONED THE PUMP STOPPED WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, THE PUMP HAD RETAINER RING RECALL NOTIFICATION. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586993 | 630G INSULIN PUMP MMT-1715KR 630G | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715KR | HG4Z9YC | 000000763000367060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |