XMTR MMT-7811NA GST3C LOCKOUT
Report
- Report Number
- 2032227-2022-325353
- Event Type
- Malfunction
- Date Received
- September 7, 2022
- Date of Event
- August 16, 2022
- Report Date
- December 21, 2022
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.
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 INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT IN B5 SECTION.
CUSTOMER REPORTS: TRANSMITTER NOT CHARGING ANOMALY. DEVICE RECEIVED, NO PHYSICAL DAMAGE TO CONNECTOR PINS, COW CATCHER OR CASE WAS NOTED PER VISUAL INSPECTION. NO TRACES OF MOISTURE / CONTAMINATION WERE NOTED AT CONNECTOR PINS PER VISUAL INSPECTION. CHECKED VOLTAGE OF TRANSMITTER AFTER UP TO TWO HOURS OF CHARGE ON GANG CHARGER. FOUND TRANSMITTER FAILED TO CHARGE WITH ONLY 0.02 V BY PLACING DEVICE IN A DIGITAL MULTIMETER. IN CONCLUSION, UNABLE TO PERFORM FUNCTIONAL, CHECK VOLTAGE TESTS DUE TO DEPLETED/LOW BATTERY. THE CUSTOMER COMPLAINT OF CHARGING ANOMALY IS CONFIRMED. 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 OBJECT ACTS 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.
CRM SERVICE NOTIFICATION TEXT (B)(6) 2022 18:50:11 ERP_RFC_USER RELATED SVN (B)(4) CRM SERVICE NOTIFICATION TEXT (B)(6) 2022 18:48:16 ERP_RFC_USER RELATED SVN (B)(4) CRM SERVICE NOTIFICATION TEXT (B)(6) 2022 18:40:54 GUTIEF11 CUSTOMER CONCERN: WANTS TO SET HER TEMP BASAL WALKTHROUGH SETTING UP TEMP BASAL. OK ALSO XMTR IS NOT CHARGING HAS RED LIGHT FLASHING EVEN THERE IS A NEW BATTER YIN THE CHARGER SEND GE XMTR ORDER DOP114-980DOC: PUMP PROGRAMMING CONFIRM CUSTOMER REQUESTS ASSISTANCE WITH PROGRAMMING THE PUMP. ADVISE TO USE REPROGRAM RESOURCES/TRANSFER SETTINGS GUIDE AVAILABLE ONLINE (WWW.MEDTRONICDIABETES.COM/DOWNLOAD-LIBRARY). DOCUMENT WHICH ITEMS WERE PROGRAMMED INTO PUMP: BASAL RATES INDICATE ANY ADDITIONAL PROGRAMMING SETTINGS: TEMP BASAL CONFIRM CUSTOMER REVIEWS PROGRAMMED SETTINGS FOR ACCURACY AND SAVES SETTINGS. FOR BASAL, HIGH SG, AND LOW SG SETTINGS, VERIFY CUSTOMER SELECTS DONE UPON CONFIRMING SETTINGS AND THEN SAVE. ONCE PROGRAMMING FOR ALL SETTINGS HAS BEEN COMPLETED, EXIT OUT OF SETTINGS SCREEN, IF APPLICABLE, AND REVIEW ALL SETTINGS TO ENSURE THEY ARE PROGRAMMED ACCURATELY BASED ON SETTINGS FROM PREVIOUS PUMP OR FROM THEIR HCP. DOES CUSTOMER CONFIRM THE SETTINGS HAVE BEEN ACCURATELY PROGRAMMED?: YES ADVISE CUSTOMER ABOUT RESOURCES AVAILABLE ON THE WEBSITE. DID CUSTOMER REPORT AN ATTEMPT TO PROGRAM BASAL RATES BUT CONFIRMED BASAL RATES DID NOT SAVE?: NO ADVISE CUSTOMER TO MONITOR PRODUCT ADVISE CUSTOMER TO MONITOR BGS ADVISE CUSTOMER TO CALL BACK AS NEEDED DOP114-980DOC: TRANSMITTER CHARGING IS CUSTOMER CALLING BACK TO REPORT INITIAL TROUBLESHOOTING WAS UNSUCCESSFUL?: NO ADVISE CUSTOMER TO REMOVE BATTERY FROM CHARGER AND CHECK THE BATTERY SPRING ON CHARGER TO DETERMINE IF IT IS DAMAGED. IS CHARGER BATTERY SPRING DAMAGED?: NO SUGGEST CUSTOMER INSTALL A NEW ALKALINE AAA BATTERY IF THEY HAVEN¿T REPLACED THE AAA BATTERY RECENTLY. BEFORE CONNECTING TRANSMITTER TO CHARGER, ADVISE CUSTOMER TO CHECK CHARGER CONNECTOR PINS TO DETERMINE IF THEY ARE INTACT. ARE CHARGER CONNECTOR PINS DAMAGED?: NO DOCUMENT LED BEHAVIOR: RED LED LIGHT ON CHARGER DOES RED LED FLASH EVERY 2 SECONDS?: NO DO A SERIES OF QUICKLY FLASHING RED LED LIGHTS DISPLAY EVERY 2 SECONDS, STOP FOR 2 SECONDS, AND REPEAT?: YES ADVISE THE TRANSMITTER BATTERY IS DEPLETED. ADVISE CUSTOMER TO LEAVE THE TRANSMITTER ON THE CHARGER FOR UP TO 2 HOURS TO COMPLETELY RECHARGE THE TRANSMITTER. HAS CUSTOMER TRIED CHARGING TRANSMITTER FOR UP TO 2 HOURS?: YES ADVISE CUSTOMER THE SERIALIZED DEVICE WILL NEED TO BE REPLACED: YES INSTRUCT CUSTOMER TO DISCONTINUE USE OF THE SERIALIZED DEVICE: YES INFORM CUSTOMER DEVICE IS OUT OF WARRANTY (OOW). IS NON-SERIALIZED PRODUCT BEING REPLACED?: NO IS NON-SERIALIZED PRODUCT BEING RETURNED?: NO
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE TRANSMITTER DID NOT CHARGE PROPERLY. CUSTOMER STATED THAT THE CHARGER HAD RED LED LIGHT. CUSTOMER STATED THAT THE CHARGER HAD A SERIES OF QUICKLY FLASHING RED LED LIGHTS THAT DISPLAYED EVERY 2 SECONDS, STOPPED FOR 2 SECONDS AND REPEATED. CUSTOMER STATED THAT THE ISSUE PERSISTED EVEN AFTER CHANGING THE BATTERY ON CHARGER AND CHARGING THE TRANSMITTER FOR TWO HOURS. CUSTOMER WAS ALSO PROVIDED ASSISTANCE IN WALKING THROUGH THE TEMP BASAL SETTING ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2485507 | XMTR MMT-7811NA GST3C LOCKOUT | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC MINIMED | MMT-7811NA | A000813737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |