PUMP MMT-1712KL 640G V4.10 BK SF MG
Report
- Report Number
- 2032227-2021-190991
- Event Type
- Malfunction
- Date Received
- September 9, 2021
- Date of Event
- August 30, 2021
- Report Date
- June 14, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 000000763000367046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 0.08695 INCHES. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/28/2021 03:38:06.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 08/28/2021 04:54:55.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 08/28/2021 06:32:58.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 08/28/2021 06:33:32.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 08/30/2021 12:02:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 08/30/2021 12:12:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 30-AUG-2021 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/27/2021 00:05:00.000, 08/27/2021 00:15:00.000, 08/30/2021 14:07:00.000, 08/30/2021 14:17:00.000. LOST SENSOR 2 ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/27/2021 00:34:00.000. 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 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/24/2021 12:29:00.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/24/2021 22:00:00.000, 08/24/2021 22:10:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/24/2021 22:31:00.000, 08/24/2021 22:41:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/24/2021 23:17:30.000, 08/30/2021 14:19:51.000, 08/30/2021 14:20:02.000, 08/30/2021 14:27:47.000, 08/30/2021 14:27:58.000 08/30/2021 14:29:48.000, 08/30/2021 14:29:59.000, 08/30/2021 14:34:04.000, 08/30/2021 14:34:14.000 08/30/2021 14:36:44.000, 08/30/2021 14:36:55.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/30/2021 14:19:17.000, 08/30/2021 14:25:37.000, 08/30/2021 14:29:21.000, 08/30/2021 14:30:37.000, 08/30/2021 14:36:01.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/30/2021 14:19:31.000, 08/30/2021 14:25:53.000, 08/30/2021 14:29:34.000, 08/30/2021 14:30:53.000, 08/30/2021 14:36:14.000. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 25-AUG-2021 AT 5:30:01 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 24-AUG-2021. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, REPLACE BATTERY ALERT AND REPLACE BATTERY NOW ALARM. UPON CHECKING ON THE POWER DATA, POWER LOSS ALARM AND PUMP ERROR 23 ALARM HAD UNLOADED VAA VOLTAGE (BATTERY VOLTAGE) OF 1.4V. THE CUSTOMER IS USING A GOOD BATTERY. 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. UNEXPECTED POWER LOSS ALARM AND PUMP ERROR 23 ALARM WERE CONFIRMED, SUSPECTED ON HW. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A KEYPAD OVERLAY PEELING, A SCRATCHED CASE AND A SERIAL NUMBER LABEL MISSING. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. UNEXPECTED POWER LOSS ALARM AND PUMP ERROR 23 ALARM WERE CONFIRMED, SUSPECTED ON HW. 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. 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.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD INSULIN FLOW BLOCK ALARM. CUSTOMER STATED THAT INSULIN WAS NOT REUSED, MIXED OR EXPIRED OR DENATURED. CUSTOMER HAD AVOIDED INSERTING AREAS WITH SCARRED TISSUE. THE TUBING WAS NOT KINKED OR BENT. CUSTOMER HAD TRIED ALL RECOMMENDED TROUBLESHOOTING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1348741 | PUMP MMT-1712KL 640G V4.10 BK SF MG | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1712KL | HG4SRKU | 000000763000367046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |