MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
Report
- Report Number
- 2032227-2022-373470
- Event Type
- Injury
- Date Received
- December 8, 2022
- Date of Event
- November 11, 2022
- Report Date
- March 26, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000521547
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- 003
Narratives
(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 NGP 780G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN 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. RETAINER RING = BLACK. CASE TYPE = NGP. THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED LOW BGS, POSSIBLE OVER DELIVERY ANOMALY AND PUMP/CARELINK COMMUNICATION ANOMALY ON 11-NOV-2022. THE PUMP PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.0873 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP UPLOADED PROPERLY USING CARELINK. THE CARELINK REPORTS (PDF AND CSV) WERE GENERATED SUCCESSFULLY. NO PUMP /CARELINK COMMUNICATION ANOMALY NOTED. THERE WERE 221 BOLUSES LISTED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE 11-NOV-2022. PLEASE SEE THE FIRST 10 BOLUSES LISTED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE 11-NOV-2022. 11/11/2022 00:01:11.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) 11/11/2022 00:06:07.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUS AMOUNT PROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U) 11/11/2022 00:11:07.000 NORMAL BOLUS DELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U) BOLUS AMOUNTDELIVERED: 1000 (0.1 U) 11/11/2022 00:16:07.000 NORMALBOLUSDELIVERED (220) BOLUS PROGRAMMING METHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUS AMOUNT DELIVERED: 750 (0.075 U)11/11/2022 00:21:07.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U)BOLUSAMOUNTDELIVERED: 750 (0.075 U) 11/11/2022 00:26:07.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U) 11/11/2022 00:31:07.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMAL BOLUS AMOUNT PROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U) 11/11/2022 00:56:03.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMAL BOLUS AMOUNT PROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U) 11/11/2022 01:01:03.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U) 11/11/2022 01:31:03.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U) THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS. POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED.COMMUNICATION ANOMALY USING CARELINK 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.
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 780G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN 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. THE INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND REPORTED POSSIBLE OVER DELIVERY AS WELL AS WAS UNABLE TO UPLOAD CARELINK. THE CUSTOMER REPORTED THAT THE BLOOD GLUCOSE WAS 30 MMOL/L SO TAKEN FOR HOSPITALIZATION FOR 2 NIGHTS. THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS UNSURE IF AUTO MODE/SMARTGUARD WAS AUTOMATICALLY DELIVERING INSULIN AT THE TIME OF LOW BLOOG GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.
THE DEVICE WAS RETURNED FOR ANALYSIS.
IT WAS UNKNOWN IF SMARTGUARD WAS USED AT THE TIME OF THE INCIDENT SINCE CALLER WAS THE DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2701826 | MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1885 | HG61JJ2ZZ | 000000763000521547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |