640G INSULIN PUMP MMT-1711K
Report
- Report Number
- 2032227-2022-178096
- Event Type
- Malfunction
- Date Received
- April 11, 2022
- Date of Event
- June 23, 2020
- Report Date
- January 24, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 00763000192136
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
(B)(4). CUSTOMER COMPLAINED THE PUMP ALARMED PUMP ERRORS. COMPLAINED THE PUMP HAS LOW BATTERY LIFE. INSULIN PUMP PASSED DISPLACEMENT TEST, SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO LOW BATTERY ALERT NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR OR PUMP ERROR NOTED DURING TEST. INSULIN PUMP SUCCESSFULLY DOWNLOADED TO THUS. CONFIRMED THE PUMP ALARMED PUMP ERROR ON 06/19/2020 09:05:24.000 AND PUMP ERROR VARIABLE 12 ON 06/19/2020 09:05:26.000 IN THE HISTORY DOWNLOAD DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB1 BOARD. NO MOISTURE DAMAGE TO THE MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLY, CRACKED BATTERY TUBE THREADS, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND CRACKED RETAINER. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO LOW BATTERY ALERT NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR OR PUMP ERROR NOTED DURING TEST. HOWEVER, CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 06/19/2020 09:05:24.000 AND PUMP ERROR VARIABLE 12 ON 06/19/2020 09:05:26.000 IN THE HISTORY DOWNLOAD DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB1 BOARD. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION 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.
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. RETAINER RING=CLEAR. CUSTOMER COMPLAINED ON 06/23/2020, THE PUMP ALARMED PUMP ERROR 4 AND PUMP ERROR 63. COMPLAINED THE PUMP HAS LOW BATTERY LIFE. PUMP PASSED DISPLACEMENT TEST, SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO LOW BATTERY ALERT NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR 4 OR PUMP ERROR 63 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 06/19/2020 09:05:24.000 AND PUMP ERROR 63 (VARIABLE=12) ON 06/19/2020 09:05:26.000 IN THE HISTORY DOWNLOAD DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB1 BOARD. NO MOISTURE DAMAGE TO THE MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLY, CRACKED BATTERY TUBE THREADS, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND CRACKED RETAINER. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO LOW BATTERY ALERT NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR 4 OR PUMP ERROR 63 NOTED DURING TEST. HOWEVER, CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 06/19/2020 09:05:24.000 AND PUMP ERROR 63 (VARIABLE=12) ON 06/19/2020 09:05:26.000 IN THE HISTORY DOWNLOAD DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB1 BOARD. 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. THE INFORMATION RELATED TO OCCUPATION HAS BEEN UPDATED AND PROVIDED IN E3 SECTION AND G2 SECTION ALSO UPDATED OF THIS REPORT.
CUSTOMER COMPLAINED ON 06/23/2020 THE PUMP ALARMED PUMP ERROR 4 AND PUMP ERROR 63. COMPLAINED THE PUMP HAS LOW BATTERY LIFE. PUMP PASSED DISPLACEMENT TEST, SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO LOW BATTERY ALERT NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR 4 OR PUMP ERROR 63 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 06/19/2020 09:05:24.000 AND PUMP ERROR 63 (VARIABLE=12) ON 06/19/2020 09:05:26.000 IN THE HISTORY DOWNLOAD DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB1 BOARD. NO MOISTURE DAMAGE TO THE MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLY, CRACKED BATTERY TUBE THREADS, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND CRACKED RETAINER. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO LOW BATTERY ALERT NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR 4 OR PUMP ERROR 63 NOTED DURING TEST. HOWEVER, CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON 06/19/2020 09:05:24.000 AND PUMP ERROR 63 (VARIABLE=12) ON 06/19/2020 09:05:26.000 IN THE HISTORY DOWNLOAD DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB1 BOARD. 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 HAD PUMP ERROR ALARMS AND LOW BATTERY ALERTS. SELF TEST PASSED. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
THE DEVICE WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425881 | 640G INSULIN PUMP MMT-1711K | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1711K | 00763000192136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |