BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15993369 · Received December 15, 2022

    Report

    Report Number
    2032227-2022-379747
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    November 19, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. THE INFORMATION RELATED TO EVENT DATE HAS BEEN UPDATED AND PROVIDED IN H6 SECTION OF THIS REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 32 MG/DL AT THE TIME OF THE EVENT AND REPORTED CHANGE SENSOR AND SENSOR UPDATING/SG VALUE NOT AVAILABLE ALERTS. THE CUSTOMER WAS HOSPITALIZED AND TREATED WITH CARBS INTAKE AND GLUCAGON AND THE CUSTOMER WENT UNCONSCIOUS AND EXPERIENCED SYMPTOM, HYPOTHERMIA.  TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER GOT ASSISTANCE WITH THE PUMP PROGRAMMING. IT WAS ALSO FOUND THAT THE AUTO MODE FEATURE WAS  NOT WORKING PROPERLY AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED VIA PHONE CALL THAT EMERGENCY MEDICAL SERVICES WERE DISPATCHED AND THAT THEY WERE AT THE EMERGENCY ROOM FOR 24 HOURS ON NOV. 19, 2022 DUE TO BEING UNCONSCIOUS AND HYPOGLYCEMIA. BLOOD GLUCOSE AT TIME OF EVENT WAS 32 MG/DL. SYMPTOMS THAT WERE REPORTED WITH THE EVENT INCLUDED HYPOTHERMIA (LOW BODY TEMPERATURE). USER WAS TREATED WITH GLUCAGON, FOOD/GLUCOSE/CARB INTAKE AND D40-50 (DEXTROSE). CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOW BLOOD GLUCOSE. BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 144 MG/DL. THE CUSTOMER HAD CALLED IN DUE TO HAVING SENSOR ISSUES, SENSOR UPDATING ALERT AND CHANGE SENSOR ALERT. ALSO STATED AUTO MODE FEATURE WAS NOT WORKING PROPERLY. SENSOR TROUBLESHOOTING WAS PROVIDED AND SENSORS WERE REPLACED. THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439543 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 HG5U31LZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other FRN-MMT-332-RSVR, UNOMED SET, MMT-SNSR-UNK