MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2021-214613
- Event Type
- Injury
- Date Received
- November 8, 2021
- Date of Event
- October 22, 2021
- Report Date
- April 20, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000414344
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
RETAINER RING = BLACK EMERGENCY MEDICAL SERVICES CAME AND GAVE INSULIN DRIP TO TREAT PATIENT. WAS NOT ADMITTED. DOCUMENT WHY THE CUSTOMER ALLEGES INSULIN PUMP IS OVER DELIVERING: SAYS THAT PUMP OVER DELIVERS AND NOT ENOUGH. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, BROKEN BATTERY THE THREADS 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. DEVICE 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 DELIVERY ACCURACY TEST AT 0.0870 INCHES. NO OVER DELIVERY ANOMALY OR UNDER DELIVERY ANOMALY NOTED. (B)(6) 202112:43:38.000 NORMALBOLUSPROGRAMMED (21), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 66000 (6.6 U), (B)(6) 2021 14:05:40.000 NORMALBOLUSPROGRAMMED (21), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 57000 (5.7 U) (B)(6)2021 18:43:40.000 NORMALBOLUSPROGRAMMED (21), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 50000 (5 U), (B)(6)2021 21:49:30.000 NORMALBOLUSPROGRAMMED (21), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 60000 (6 U), (B)(6)2021 23:53:02.000 NORMALBOLUSPROGRAMMED (21), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 27000 (2.7 U) ,(B)(6)2021 17:17:41.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). THERE WAS NO "NO DELIVERY ALARM" OR AUTO SUSPEND NOTED IN THE INSULIN PUMP HISTORY FILE. DEVICE PASSED THE FUNCTIONAL TESTING. NO OVER DELIVERY ANOMALY OR UNDER DELIVERY ANOMALY NOTED. UNABLE TO CONFIRM ALLEGED LOW BLOOD GLUCOSE'S AND HIGH BLOOD GLUCOSE'S. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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.
UPDATED ANALYSIS SUMMARY BY (B)(6) ON APRIL 06, 2022 RETAINER RING = BLACK. ON (B)(6), 2021, THE CUSTOMER ALLEGED FOR EMS CAME AND GAVE IV TO TREAT PATIENT. WAS NOT ADMITTED. DOCUMENT WHY THE CUSTOMER ALLEGES PUMP IS OVER DELIVERING: SAYS THAT PUMP OVER DELIVERS AND NOT ENOUGH. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, BROKEN BATTERY THE THREADS 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. DEVICE 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 TEST AT 0.0870 INCHES. NO OVER DELIVERY ANOMALY OR UNDER DELIVERY ANOMALY NOTED. 10/22/2021 12:43:38.000 NORMALBOLUSPROGRAMMED (21) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 66000 (6.6 U) 10/22/2021 14:05:40.000 NORMALBOLUSPROGRAMMED (21) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 57000 (5.7 U) 10/22/2021 18:43:40.000 NORMALBOLUSPROGRAMMED (21) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 50000 (5 U) 10/22/2021 21:49:30.000 NORMALBOLUSPROGRAMMED (21) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 60000 (6 U) 10/22/2021 23:53:02.000 NORMALBOLUSPROGRAMMED (21) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 27000 (2.7 U) 10/22/2021 17:17:41.000 INSULINDELIVERYSTOPPED (30) REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) THERE WAS NO "NO DELIVERY ALARM" OR AUTO SUSPEND NOTED IN THE PUMP HISTORY FILE. DEVICE PASSED THE FUNCTIONAL TESTING. CUSTOMER ALLEGED FOR THE PUMP OVER DELIVERY WAS NOT CONFIRMED. UNABLE TO CONFIRM ALLEGED LOW BG'S AND HIGH BG'S. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 35 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH IV DRIP. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 191 MG/DL. CUSTOMER WAS NOT USING AUTO MODE FEATURE AT THE TIME OF THE INCIDENT. CUSTOMER BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS AT THE TIME OF THE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1664865 | MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1880 | HG4VJAUZZ | 000000763000414344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Hospitalization | FRN-MMT-332-RSVR, OZO-UNK-SENSR, UNOMED SET |