MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2022-170902
- Event Type
- Malfunction
- Date Received
- March 25, 2022
- Date of Event
- October 4, 2021
- Report Date
- April 21, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000414344
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). S/W 5.2A; RETAINER RING: BLACK. THE PUMP WAS RETURNED FOR PUMP ERROR 41 ALARM AND PUMP ERROR 43 ALARM PER EVENT DATE (B)(6) 2021. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO DAMAGE TO RETAINER RING DURING VISUAL INSPECTION NOTED. THE PUMP PASSED THE DISPLACEMENT TEST, AND SELF-TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES USING THUS SOFTWARE. NO UNEXPECTED OCCLUSIONS OR DELIVERY ANOMALY, BOLUS ANOMALY OR BASAL ANOMALY NOTED ON DOWNLOAD HISTORY FILE. HOWEVER PUMP ERROR 41 ALARM AND PUMP ERROR 43 WERE CONFIRMED ON LONG HISTORY FILE ON (B)(6) 2021 11:51:00 AND (B)(6) 2021 11:51:14:00 DUE TO HARDWARE ERROR. (MOTOR CURRENT ERROR), PROBLEM ISOLATED TO ELECTRONICS ASSEMBLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION, CRACKED BATTERY TUBE THREADS, DAMAGE KEYPAD OVERLAY TEXTURE AND CRACKED CASE AT BATTERY TUBE SIDE. UNIT WAS CONFIRMED FOR PUMP ERROR 41 ALARM AND PUMP ERROR 43 ALARM WERE CONFIRMED DURING LONG HISTORY FILE ON (B)(6) 2021 11:51:00 AND (B)(6) 2021 11:51:14:00 DUE TO HARDWARE ERROR, PROBLEM ISOLATED TO ELECTRONICS ASSEMBLY. 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.
RETAINER RING = BLACK. THE PUMP WAS RETURNED FOR PUMP ERROR 41 ALARM AND PUMP ERROR 43 ALARM PER EVENT DATE 10/04/2021. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO DAMAGE TO RETAINER RING DURING VISUAL INSPECTION NOTED. THE PUMP PASSED THE DISPLACEMENT TEST, AND SELF-TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES USING THUS SOFTWARE. NO UNEXPECTED OCCLUSIONS OR DELIVERY ANOMALY, BOLUS ANOMALY OR BASAL ANOMALY NOTED ON DOWNLOAD HISTORY FILE. HOWEVER PUMP ERROR 41 ALARM AND PUMP ERROR 43 WERE CONFIRMED ON LONG HISTORY FILE ON 10/04/2021 11:51:00 AND 10/04/2021 11:51:14:00 DUE TO HARDWARE ERROR. (MOTOR CURRENT ERROR), PROBLEM ISOLATED TO ELECTRONICS ASSEMBLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION, CRACKED BATTERY TUBE THREADS, DAMAGE KEYPAD OVERLAY TEXTURE AND CRACKED CASE AT BATTERY TUBE SIDE. UNIT WAS CONFIRMED FOR PUMP ERROR 41 ALARM AND PUMP ERROR 43 ALARM WERE CONFIRMED DURING LONG HISTORY FILE ON 10/04/2021 11:51:00 AND 10/04/2021 11:51:14:00 DUE TO HARDWARE ERROR, PROBLEM ISOLATED TO ELECTRONICS ASSEMBLY. 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 INSULIN PUMP ALARMED MULTIPLE PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE DISPLACEMENT AND SELF TEST WERE PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, THE CUSTOMER WILL CONTINUE THE USE OF DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 935885 | 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 | HG4XMV8ZZ | 000000763000414344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Male |