MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-198377
- Event Type
- Malfunction
- Date Received
- April 27, 2023
- Date of Event
- April 12, 2023
- Report Date
- July 12, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000545499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
S.W VERSION UNKNOWN RETAINER RING = BLACK CASE TYPE = NGP CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON 12-APR-2023. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 3 ALARMS ON 04/11/2023 AT 21:32:32.000 AND 04/11/2023 21:40:00.000 ACCORDING IN THE ERROR LOG FILE/DETAILED TRACE FILE. AS PER GLOBAL LOGIC ANALYSIS (ESF#3923533), PUMP ERROR 3 ALARMS (LINE NUMBER 1541 FILE NUMBER 2002), SUSPECTED ON HW. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 12-APR-2023 IN THE FORMATTED HISTORY FILE. LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 07:51:00.000 04/11/2023 01:02:00.000 SGCALIBRATIONERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/10/2023 11:40:59.000 04/10/2023 17:47:39.000 UNABLE TO TEST FOR LOST SENSOR1 ALERT AND SG CALIBRATION ERROR DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR1 ALERT AND SG CALIBRATION ERROR WERE UNKNOWN. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. ¿ TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO THREE CONSECUTIVE PUMP ERROR 3 ALARMS. PUMP ERROR 3 ALARM, SUSPECTED ON HW. 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 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. 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 INSULIN PUMP INVOLVED IN THIS EVENT IS THE 770G OUS INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A SERIOUS PUMP ERROR (THE PICTURE OF THE BOOK) AND THERE WAS NO IMPROVEMENT EVEN WHEN THE BATTERY WAS REMOVED. IT WAS STATED THAT THE PUMP GOT ERRORS WHEN THE BATTERY WAS REMOVED AND RE-INSERTED. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER DETAILS WERE GIVEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1157246 | MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1882 | NG3317310H | 000000763000545499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |