630G INSULIN PUMP MMT-1715KL 630G
Report
- Report Number
- 2032227-2024-134032
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- February 14, 2024
- Report Date
- April 17, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 000000763000316655
- PMA / PMN Number
- P150001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 003
Narratives
PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY MULTIPLE CONSECUTIVE PUMP ERROR 53 ALARMS ON 2/14/2024 AT 10:09:44 AM, 2/14/2024 AT 10:09:58 AM, 2/14/2024 AT 10:11:55 AM, 2/14/2024 AT 10:12:00 AM, 2/14/2024 AT 10:12:14 AM AND 2/14/2024 AT 10:12:17 AM ACCORDING IN THE DETAILED TRACE FILE/FORMATTED HISTORY FILE. PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR (LINE NUMBER = 5632 ; FILE NUMBER = 2005). PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 14-FEB-2024 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/14/2024 09:25:00.000. SENSOR ERROR ALERT (801) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/13/2024 14:46:49.000. ON 02/13/2024 14:56:00.000. ON 02/13/2024 15:16:58.000. ON 02/13/2024 15:26:00.000. ON 02/13/2024 15:51:49.000. ON 02/13/2024 16:01:00.000. SG CALIBRATION ERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/13/2024 13:54:39.000 CANNOT FIND SENSOR SIGNAL 1 ALERT (790) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/14/2024 03:45:00.000. UNABLE TO TEST FOR LOST SENSOR ALERT, SENSOR ERROR ALERT, SG CALIBRATION ERROR AND CANNOT FIND SENSOR SIGNAL ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT, SENSOR ERROR ALERT, SG CALIBRATION ERROR AND CANNOT FIND SENSOR SIGNAL ALERT WERE UNKNOWN. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/13/2024 14:25:00.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/14/2024 09:47:56.000. ON 02/14/2024 10:09:16.000. ON 02/14/2024 10:09:26.000. ON 02/14/2024 10:09:29.000. ON 02/14/2024 10:09:38.000. ON 02/14/2024 10:09:58.000. ON 02/14/2024 10:12:14.000. O 02/14/2024 10:12:17.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/14/2024 10:09:38.000. ON 02/14/2024 10:11:55.000. ON 02/14/2024 10:12:17.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/13/2024 23:56:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/14/2024 00:27:00.000. ON 02/14/2024 00:37:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/14/2024 03:36:24.000. 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A LOW/NO POWER/DEPLETED BATTERY. UNABLE TO TEST FOR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE UNKNOWN. 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO MULTIPLE CONSECUTIVE PUMP ERROR 53 ALARMS. PUMP ERROR 53 ALARMS DUE TO SOFTWARE ERROR. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
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 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 CUSTOMER EXPERIENCED A CRITICAL PUMP ERROR/OPEN BOOK IMAGE ALARM. TROUBLESHOOTING WAS PERFORMED AND EXPLAINED THE INSULIN PUMP PERFORMED SAFETY CHECKS AND THE ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE PUMP AND REVERT TO BACK UP PLAN AS PER THE HEALTH CARE PROFESSIONAL INSTRUCTIONS AND SERIALIZED DEVICE WILL BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR FAILURE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497460 | 630G INSULIN PUMP MMT-1715KL 630G | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715KL | HG5T94W | 000000763000316655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female |