630G INSULIN PUMP MMT-1715K 630G BLACK MG
Report
- Report Number
- 2032227-2023-286011
- Event Type
- Injury
- Date Received
- October 19, 2023
- Date of Event
- September 20, 2023
- Report Date
- November 22, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 000000763000190439
- PMA / PMN Number
- P150001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
CUSTOMER RETURNED PUMP FOR AN ALLEGED EMS DISPATCHED FOR LOSS OF CONSCIOUSNESS AND LOW BGS FOUND ON (B)(6) 2023. ON CASE: (B)(4), SVN#: (B)(6), CUSTOMER RETURNED PUMP FOR AN ALLEGED BLANK DISPLAY FOUND ON (B)(6) 2019. ON CASE: (B)(4), SVN#: (B)(6), CUSTOMER RETURNED PUMP FOR AN ALLEGED HIGH BGS FOUND ON (B)(6) 2023. THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. 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 0.08670 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 21-AUG-2019, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 21-AUG-2019 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED = 17.725. DAILY TOTAL OF BASAL INSULIN DELIVERED = 10.825. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 6.9. ON (B)(6) 2019 22:46:02.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 6.9. BOLUS AMOUNT DELIVERED = 6.9. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 21-AUG-2019 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2019 08:20:29.000. ON (B)(6) 2019 09:08:19.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2019 22:12:00.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2019 07:43:00.000. ON (B)(6) 2019 07:53:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2019 08:14:00.000. ON (B)(6) 2019 08:24:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2019 08:26:00.000, ON (B)(6) 2019 08:36:00.000, ON (B)(6) 2019 09:20:12.000, ON (B)(6) 2019 09:20:23.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2019 09:19:03.000. 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2023 AT 10:37:00 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE ON (B)(6) 2019. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND PUMP ERROR 23 ALARM. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND PUMP ERROR 23 ALARM NOTED DURING TESTING. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 24-SEP-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 24-SEP-2023 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED = 54.8. DAILY TOTAL OF BASAL INSULIN DELIVERED = 41.6. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 13.2. ON (B)(6) 2023 13:50:32.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 10. BOLUS AMOUNT DELIVERED = 10. ON (B)(6) 2023 20:15:26.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 3.2. BOLUS AMOUNT DELIVERED = 3.2. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 24-SEP-2023 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 20-SEP-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 20-SEP-2023 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED = 47.45. DAILY TOTAL OF BASAL INSULIN DELIVERED = 41.75. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 5.7. ON (B)(6) 2023 11:49:34.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 5.7. BOLUS AMOUNT DELIVERED = 5.7. 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 BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 20-SEP-2023 IN THE FORMATTED HISTORY FILE. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.6 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT; HOWEVER, A CRACKED RETAINER AND A CRACKED RESERVOIR TUBE LIP WERE NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL PEELING. RETAINER RING DAMAGE (A CRACKED RETAINER AND A CRACKED RESERVOIR TUBE LIP) WAS CONFIRMED. BLANK DISPLAY WAS NOT CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS AND HIGH BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. 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. 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 HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 52 MG/DL. THE CUSTOMER WAS EMERGENCY MEDICAL SERVICES. IT WAS ALSO REPORTED THAT THE RETAINER RING NOTIFICATION. TROUBLESHOOTING WAS PARTIALLY PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. IT WAS UNKNOWN WHETHER THE AUTO-MODE FEATURE WAS ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89896 | 630G INSULIN PUMP MMT-1715K 630G BLACK MG | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715K | HG3AVP7 | 000000763000190439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Other| R | FRN-MMT-332A-RSVR, UNOMED INF SET. |