640G INSULIN PUMP MMT-1712K
Report
- Report Number
- 2032227-2023-196470
- Event Type
- Malfunction
- Date Received
- April 26, 2023
- Date of Event
- April 10, 2023
- Report Date
- July 4, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 000000763000317157
- Removal / Correction Number
- 2032227-060322-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- 003
Narratives
THE PUMP WAS RECEIVED WITH A LOOSE METAL CONTACT ON THE BATTERY CAP DUE TO A BROKEN THREE HEAT STAKE POST. A TEST BATTERY CAP LOCKS SECURELY INTO PLACE AND THE PUMP POWERED UP PROPERLY. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. 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 0.08740 INCHES. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY DOWNLOADED COMLINK3 FILE. THERE WERE NO FATAL CRITICAL ALARMS, OR THREE CONSECUTIVE CRITICAL HANDLING ALARMS FOUND IN THE FORMATTED HISTORY FILE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS DUE TO THE RF TEST FAILURE IN THE BOOTLOADER (CODE 0X00000045). SUSPECTING HW ISSUE. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 10-APR-2023 IN THE FORMATTED HISTORY FILE. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:03:53.000, 04/10/2023 00:04:32.000, 04/10/2023 00:04:43.000, 04/10/2023 00:04:43.000, 04/10/2023 00:05:17.000, 04/10/2023 00:08:27.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:03:39.000, 04/10/2023 00:08:39.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:00:05.000, 04/10/2023 00:01:29.000, 04/10/2023 00:01:54.000, 04/10/2023 00:02:17.000, 04/10/2023 00:02:27.000, 04/10/2023 00:03:45.000, 04/10/2023 00:03:53.000, 04/10/2023 00:04:32.000, 04/10/2023 00:04:43.000, 04/10/2023 00:05:17.000, 04/10/2023 00:08:27.000. PUMP ERROR 68 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:08:57.000. PUMP ERROR 49 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:08:57.000, 04/10/2023 00:09:08.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:09:19.000. 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. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY NOW ALARM NOTED 1 WEEK PRIOR TO THE EVENT DATE 10-APR-2023 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND REPLACE BATTERY ALERT WERE EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE EXPECTED SINCE THE PUMP RESTART DUE TO POWER LOSS. SG CALIBRATION ERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/04/2023 09:31:42.000, 04/04/2023 11:40:10.000, 04/04/2023 16:05:11.000, 04/04/2023 16:05:11.000. SENSOR ERROR ALERT (801) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/04/2023 11:40:10.000, 04/04/2023 12:15:33.000, 04/04/2023 12:50:05.000, 04/04/2023 13:20:14.000, 04/04/2023 16:05:26.000, 04/04/2023 16:40:03.000, 04/04/2023 23:10:02.000, 04/04/2023 23:26:00.000, 04/06/2023 06:05:10.000, 04/06/2023 06:40:11.000, 04/06/2023 07:15:03.000, 04/06/2023 07:45:43.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SG CALIBRATION ERROR, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. PUMP ERROR 4 ALARM (FILE NUMBER: 32122 LINE NUMBER: 2727) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:00:01.000. PUMP ERROR 63 ALARM (FILE NUMBER: 2005 LINE NUMBER: 9926) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:00:02.000. PUMP ERROR 4 ALARM (FILE NUMBER: 32122 LINE NUMBER: 2727) AND PUMP ERROR 63 ALARM (FILE NUMBER: 2005 LINE NUMBER: 9926) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 00:01:51.000 PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. 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. HOWEVER, SLIGHT CORROSION WAS FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. 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, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. BATTERY CAP CONTACT MISSING/DAMAGED WAS CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED SUSPECTED ON HW. PUMP ERROR 4 ALARM (FILE NUMBER: 32122 LINE NUMBER: 2727) AND PUMP ERROR 63 ALARM (FILE NUMBER: 2005 LINE NUMBER: 9926) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. DURING VISUAL INSPECTION, SLIGHT CORROSION WAS FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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 CUSTOMER RECEIVED OPEN BOOK IMAGE. IT WAS REPORTED THAT THE CUSTOMER WAS AT WORK AT THE TIME OF EVENT AND WAS NOT EXPOSED TO WATER. TROUBLESHOOTING WAS PERFORMED, HOWEVER, THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792292 | 640G INSULIN PUMP MMT-1712K | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1712K | HG551DB | 000000763000317157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |