MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-187874
- Event Type
- Malfunction
- Date Received
- April 13, 2023
- Date of Event
- March 28, 2023
- Report Date
- May 11, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000545604
- PMA / PMN Number
- P160017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT, PUMP PASSED SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, AND OCCLUSION TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. PUMP SUCCESSFULLY DOWNLOADED TO THUS/THUMP. CONFIRMED PUMP ALARM INSULIN FLOW BLOCKED ALARM ON 03/21/2023 A TIME 04:13:00.000 DURING BASAL, ON 03/21/2023 AT TIME 04:23:00.000 DURING BASAL, ON 03/21/2023 AT TIME 06:43:00.000 DURING PRIMING, ON 03/21/2023 AT TIME 06:53:00.000 DURING PRIMING, ON 03/21/2023 AT TIME 10:23:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 10:33:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 11:14:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 11:24:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 13:00:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 13:02:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 13:03:52.000 DURING PRIMING, ON 03/21/2023 AT TIME 13:08:37.000 DURING BOLUS, ON 03/21/2023 AT TIME 13:09:00.000 DURING BOLUS, ON 03/21/2023 AT TIME 13:54:00.000 DURING PRIMING, ON 03/21/2023 AT TIME 14:04:00.000 DURING PRIMING, ON 03/21/2023 AT TIME 23:26:00.000 DURING BASAL, ON 03/21/2023 AT TIME 23:52:58.000 DURING BOLUS, ON 03/21/2023 AT TIME 23:54:00.000 DURING BOLUS, ON 03/22/2023 AT TIME 03:05:00.000 DURING BOLUS, ON 03/22/2023 AT TIME 03:15:00.000 DURING BOLUS, ON 03/23/2023 AT TIME 06:54:00.000 DURING BASAL, 03/23/2023 AT TIME 07:04:00.000 DURING BASAL, ON 03/23/2023 AT TIME 07:38:00.000 DURING BASAL, ON 03/23/2023 AT TIME 07:39:01.000 DURING BASAL, ON 03/23/2023 AT TIME 07:40:00.000 DURING BASAL, ON 03/23/2023 AT TIME 07:41:00.000 DURING BASAL, ON 03/23/2023 AT TIME 07:42:00.000 DURING BASAL, ON 03/23/2023 AT TIME 16:27:00.000 DURING BOLUS, ON 03/23/2023 AT TIME 16:37:00.000 DURING BOLUS, ON 03/23/2023 AT TIME 18:56:57.000 DURING PRIMING, ON 03/23/2023 AT TIME 18:58:00.000 DURING BOLUS, ON 03/25/2023 AT TIME 12:51:00.000 DURING BASAL, ON 03/25/2023 AT TIME 12:52:00.000 DURING BASAL, ON 03/25/2023 AT TIME 17:49:00.000 DURING PRIMING, 03/25/2023 AT TIME 17:52:26.000. DURING PRIMING, ON 03/25/2023 AT TIME 17:53:00.000 DURING REWIND, ON 03/25/2023 AT TIME 17:54:00.000 DURING PRIMING, ON 03/25/2023 AT TIME 17:55:00.000 DURING PRIMING, ON 03/25/2023 AT TIME 17:56:00.000 DURING PRIMING, ON 03/25/2023 AT TIME 17:59:42.000 DURING PRIMING, ON 03/25/2023 AT TIME 18:09:00.000 DURING PRIMING, ON 03/25/2023 AT TIME 18:42:44.000 DURING PRIMING, ON 03/25/2023 AT TIME 18:43:40.000 DURING BOLUS, ON 03/25/2023 AT TIME 18:44:40.000 DURING BOLUS, ON 03/25/2023 AT TIME 18:47:00.000 DURING BOLUS, ON 03/25/2023 AT TIME 18:57:00.000 DURING BOLUS, ON 03/26/2023 AT TIME 08:37:00.000 DURING BOLUS, ON 03/26/2023 AT TIME 08:41:00.000 DURING BOLUS, ON 03/26/2023 AT TIME 10:56:13.000 DURING BOLUS, ON 03/26/2023 AT TIME 10:59:01.000 DURING BOLUS, ON 03/26/2023 AT TIME 11:00:00.000 DURING BOLUS, ON 03/26/2023 AT TIME 00:13:00.000 DURING BASAL, ON 03/26/2023 AT TIME 00:23:00.000 DURING BASAL, ON 03/26/2023 AT TIME 00:31:00.000 DURING BASAL, ON 03/26/2023 AT TIME 00:33:00.000 DURING BASAL, ON 03/26/2023 AT TIME 00:48:30.000 DURING BOLUS, ON 03/26/2023 AT TIME 10:49:00.000 DURING BASAL, ON 03/26/2023 AT TIME 10:59:00.000 DURING BASAL, ON 03/26/2023 AT TIME 11:27:00.000 DURING PRIMING, ON 03/26/2023 AT TIME 11:37:00.000 DURING PRIMING, ON 03/27/2023 AT TIME 00:39:00.000 DURING BASAL, ON 03/27/2023 AT TIME 00:48:00.000 DURING BASAL, ON 03/27/2023 AT TIME 02:20:00.000 DURING PRIMING, ON 03/27/2023 AT TIME 06:11:00.000 DURING BOLUS, ON 03/27/2023 AT TIME 06:21:00.000 DURING BOLUS, ON 03/27/2023 AT TIME 06:34:55.000 DURING BOLUS, ON 03/27/2023 AT TIME 06:43:00.000 DURING BOLUS, DURING BASAL, ON 03/27/2023 AT TIME 09:40:05.000 DURING BOLUS, ON 03/27/2023 AT TIME 10:13:00.000 DURING BOLUS, ON 03/27/2023 AT TIME 10:14:00.000 DURING BOLUS, ON 03/27/2023 AT TIME 11:14:52.000 DURING BOLUS, ON 3/28/2023 AT TIME 02:02:43.000 DURING BOLUS, ON 03/28/2023 AT TIME 02:57:26.000 DURING BOLUS, ON 03/28/2023 AT TIME 03:17:00.000 DURING BOLUS, ON 03/28/2023 AT TIME 03:32:03.000 DURING BOLUS, ON 03/28/2023 AT TIME 15:49:18.000 DURING PRIMING, ON 03/28/2023 AT TIME 15:51:03.000 DURING PRIMING, ON 03/28/2023 AT TIME 15:54:16.000 DURING PRIMING, ON 03/28/2023 AT TIME 15:58:01.000 DURING PRIMING, ON 03/28/2023 AT TIME 15:59:00.000 DURING BASAL, ON 03/28/2023 AT TIME 16:03:28.000 DURING PRIMING, ON 03/28/2023 AT TIME 16:04:20.000 DURING PRIMING, ON 03/28/2023 AT TIME 16:10:59.000 DURING PRIMING, AND ON 03/28/2023 AT TIME 16:13:00.000 DURING PRIMING IN PUMP DOWNLOADED HISTORY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY. IN SUMMARY, CUSTOMERS ALLEGED NO DELIVERY/OCCLUSION ALARM DURING PRIMING WAS NOT CONFIRMED DURING TESTING. PUMP PASSED FULL DRIVE TEST. NO UNEXPECTED INSULIN FLOW ALARMS NOTED IN PUMP HISTORY DOWNLOAD. NO ANOMALIES NOTED ON ELECTRONIC/MOTOR ASSEMBLIES. 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. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 RECEIVED AN INSULIN FLOW BLOCK ALARM DURING THE FILLING THE TUBING. THE TROUBLESHOOTING WAS PERFORMED AND ADVISED THE CUSTOMER TO CLEAR THE ALARM AND THE PUMP PASSED THE SELF-TEST AND DISPLACEMENT TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND WILL BE RETURNED FOR PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1455630 | MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1880 | NG3271683H | 000000763000545604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |