630G INSULIN PUMP MMT-1715KR 630G
Report
- Report Number
- 2032227-2023-206365
- Event Type
- Injury
- Date Received
- May 12, 2023
- Date of Event
- April 18, 2023
- Report Date
- February 27, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 000000763000367060
- PMA / PMN Number
- P150001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
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 0.08750 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 08/24/2022 TO 01/08/2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARMS/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE SS EVENT DATE OF 03-MAY-2022 AND CUSTOMER EVENT DATE OF 03-APR-2022. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE SS EVENT DATE OF 03-MAY-2022 AND CUSTOMER EVENT DATE OF 03-APR-2022 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 02-SEP-2022, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 02-SEP-2022 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME = 09/02/2022 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED = 45.175, DAILYTOTALOFBASALINSULINDELIVERED = 32.6, DAILYTOTALOFBOLUSINSULINDELIVERED = 12.575. 09/02/2022 10:01:00.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD, NORMALBOLUSAMOUNTPROGRAMMED = 2.875, BOLUSAMOUNTDELIVERED = 2.875. 09/02/2022 12:47:09.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD, NORMALBOLUSAMOUNTPROGRAMMED = 2.325, BOLUSAMOUNTDELIVERED = 2.325. 09/02/2022 14:27:58.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD, NORMALBOLUSAMOUNTPROGRAMMED = 1, BOLUSAMOUNTDELIVERED = 1. 09/02/2022 17:26:45.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = MANUAL BOLUS, NORMALBOLUSAMOUNTPROGRAMMED = 1, BOLUSAMOUNTDELIVERED = 1. 09/02/2022 17:49:03.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = MANUAL BOLUS, NORMALBOLUSAMOUNTPROGRAMMED = 2, BOLUSAMOUNTDELIVERED = 2. 09/02/2022 21:43:45.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD, NORMALBOLUSAMOUNTPROGRAMMED = 3.375, BOLUSAMOUNTDELIVERED = 3.375. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 02-SEP-2022 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/27/2022 15:03:00.000. CANNOT FIND SENSOR SIGNAL 1 ALERT (790) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/27/2022 15:14:00.000. SG CALIBRATION ERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/31/2022 19:26:01.000. 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¿. NO PUMP/TRANSMITTER COMMUNICATION ANOMALY NOTED. 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, CANNOT FIND SENSOR SIGNAL ALERT, SG CALIBRATION ERROR OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 18-APR-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 OF 18-APR-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME = 04/18/2023 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED = 38.1, DAILYTOTALOFBASALINSULINDELIVERED = 35, DAILYTOTALOFBOLUSINSULINDELIVERED = 3.1. 04/18/2023 09:00:54.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD, NORMALBOLUSAMOUNTPROGRAMMED = 3.1, BOLUSAMOUNTDELIVERED = 3.1. 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 18-APR-2023 IN THE FORMATTED HISTORY FILE. 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 TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS/HIGH BGS/DKA. CUSTOMER ALLEGED FOR PUMP/TRANSMITTER COMMUNICATION ANOMALY WAS NOT CONFIRMED. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.
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 HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 & H6( HECC,HEIC) WITH THIS REPORT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND HYPOGLYCEMIA WITH THE BLOOD GLUCOSE VALUE OF 21 MG/DL OF LOW BLOOD GLUCOSE MEASUREMENT, ALONG WITH DIABETIC KETOACIDOSIS, GOT TREATED IN HOSPITAL. TROUBLESHOOTING WAS NOT PERFORMED. IT IS UNKNOWN WHETHER THE PUMP WAS USED WITHIN 48 HOURS OF THE REPORTED EVENT OR NOT. NO FURTHER CUSTOMER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE OR DISCONTINUE USE OF THE DEVICE AND THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
UPDATED SUMMARY: IT WAS REPORTED THAT CUSTOMER ALSO EXPERIENCED HYPERGLYCEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044345 | 630G INSULIN PUMP MMT-1715KR 630G | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715KR | HG5F42V | 000000763000367060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Other| H| R | FRN-332-RSVR,UNOMED SET,MDS-7811-XMTR,OZP-7020-SNS |