BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12703072 · Received October 27, 2021

    Report

    Report Number
    2032227-2021-210844
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    October 5, 2021
    Report Date
    August 7, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 WITH INITIAL MDR WAS INCOMPLETE. THE COMPLETE INFORMATION HAS BEEN UPDATED IN B5 AND H6 SECTION FO THIS REPORT.

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK. ON (B)(6) 2021, CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: HIGH BGS/UNDER DELIVERY. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAIN CALL THAT MIGHT OF TRIGGER THE REASON COMPLAIN. UNIT PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. DURING DOWNLOAD REVIEW NO RELEVANT ALARMS CONFIRM IN DOWNLOAD HISTORY FILES TO CONFIRM COMPLAIN CODE. PROCEED IT BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION NO MOISTURE DAMAGE ON ANOMALIES NOTED DURING VISUAL INSPECTION. UNIT RECEIVED WITH CRACKED KEYPAD AT SELECT BUTTON AND MISSING DISPLAY WINDOW COVER. IN CONCLUSION, CUSTOMER CONCERNS ARE NOT CONFIRMED. NO RELEVANT ALARMS NOTED IN DOWNLOAD HISTORY REVIEW AND TESTING OF THE UNIT WAS SUCCESSFUL. (B)(4). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH PRESSION TEST WAS NOT PASSED. CUSTOMER WAS ADVISED TO RETEST THE INSULIN PUMP BUT IT FAILED AGAIN.

    Additional Manufacturer Narrative · 1

    (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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE LEVELS AT THE TIME OF INCIDENT WAS 400 MG/DL. CUSTOMER WAS USING INSULIN PUMP WITHIN 48 HOURS OF REPORTING HIGH BLOOD GLUCOSE EVENT . CUSTOMER WAS USING AUTO MODE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602224 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 HG4TD3GZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Other FRN-MMT-332-RSVR,UNOMED-INF SET,OZP-MMT-7020.| FRN-MMT-332-RSVR,UNOMED-INF SET,OZP-MMT-7020