MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-282244
- Event Type
- Malfunction
- Date Received
- October 11, 2023
- Date of Event
- September 17, 2023
- Report Date
- November 24, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000545604
- PMA / PMN Number
- P150001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
S.W VERSION 5.3A. RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED PUMP FOR AN ALLEGED MISSING SEGMENTS/PARTIAL DISPLAY AND FAILED BATTERY ALERT/BATTERY FAILED ALARM FOUND ON 17-SEP-2023. PUMP WAS RECEIVED WITH A MISSING SEGMENTS/PARTIAL DISPLAY AND VERTICAL LINES ON THE DISPLAY. PUMP FAILED THE SELF TEST DUE TO MISSING SEGMENTS/PARTIAL DISPLAY AND VERTICAL LINES ON THE DISPLAY. HOWEVER, THE PUMP PASSED THE LED TEST, VIBRATION TEST AND TONE TEST. THE PUMP PASSED THE DISPLACEMENT TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. PUMP WAS MONITORED AND NO FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. NO ALARMS OR ALERTS NOTED DURING THE TESTING. NO FAILED BATTERY ALERT/BATTERY FAILED ALARM, POWER ERROR 25 ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/16/2023 20:42:00.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/16/2023 20:43:32.000, 09/16/2023 20:45:27.000, 09/16/2023 20:47:37.000, 09/16/2023 20:48:40.000, 09/16/2023 20:50:49.000, 09/16/2023 20:52:38.000, 09/16/2023 20:49:47.000, 09/17/2023 13:12:38.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/17/2023 13:14:16.000, 09/17/2023 13:14:24.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/17/2023 13:13:40.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED. UPON CHECKING ON THE POWER DATA, LOW BATTERY ALERT UNLOADED VAA VOLTAGE (BATTERY VOLTAGE) OF 1.528 V. THE CUSTOMER IS USING A GOOD BATTERY. LOW BATTERY ALERT WAS UNEXPECTED. 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. A MISSING SEGMENTS/PARTIAL DISPLAY AND VERTICAL LINES ON THE DISPLAY WERE CONFIRMED, PROBLEM ISOLATED ON THE LCD/PCBA1. THE ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. UNEXPECTED LOW BATTERY ALERT AND A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WERE CONFIRMED, SUSPECTED ON PCBA 1. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 17-SEP-2023 IN THE FORMATTED HISTORY FILE. SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/15/2023 06:44:07.000 THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR EXPIRED ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. PUMP ERROR 29 (FILENUMBER 39 LINENUMBER 645) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/16/2023 20:44:48.000, 09/16/2023 20:47:09.000. PUMP ERROR 29 (FILENUMBER 39 LINENUMBER 645) WAS CONFIRMED, SUSPECTED ON HW. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. A MISSING SEGMENTS/PARTIAL DISPLAY AND VERTICAL LINES ON THE DISPLAY WERE CONFIRMED, PROBLEM ISOLATED ON THE LCD/PCBA1. PUMP ERROR 29 (FILENUMBER 39 LINENUMBER 645) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS NOT CONFIRMED. HOWEVER, UNEXPECTED LOW BATTERY ALERT AND A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WERE CONFIRMED, SUSPECTED ON PCBA 1. 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 WAS FACING AN ISSUE WITH MISSING SEGMENTS ON THE DISPLAY OF THE PUMP. CUSTOMER STATED THAT DISPLAY WAS DISTURBED AFTER CHANGING THE BATTERY. TROUBLESHOOTING WAS PERFORMED AND DISPLAY WAS PARTIAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. ADVISED CUSTOMER TO REPLACE PUMP. THE CUSTOMER WILL DISCONTINUE THE USAGE OF THE PUMP AND REVERT TO HEALTH CARE PROFESSIONAL¿S PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1768193 | 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 | NG3213752H | 000000763000545604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |