BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16202848 · Received January 19, 2023

    Report

    Report Number
    2032227-2023-129723
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    January 5, 2023
    Report Date
    February 28, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED DKA, INSULIN FLOW BLOCK ALARM AND PUMP ERROR 43 ON 05-JAN-2023. ON SVN (B)(6) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED DKA/HIGH BGS ON 15-AUG-2022. ON SVN (B)(6) THE CUSTOMER ALLEGED INSULIN FLOW BLOCKED ALARM AND HIGH BGS ON 28-OCT-2022. ON SVN (B)(6) THE CUSTOMER ALLEGED PUMP ERROR 43 ON 04-NOV-2022. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0870 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY AND CRACKED CASE ABOVE THE BATTERY ICON AT THE BATTERY TUBE. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. PLEASE SEE BELOW THE NO DELIVERY ALARM LISTED ON THE EVENT DATES 05-JAN-2023 AND 28-OCT-2022 IN THE PUMP HISTORY FILE. 01/05/2023 09:29:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 10:42:22.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS 10/28/2022 11:05:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 11:20:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 11:30:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 11:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 11:50:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 11:52:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL 10/28/2022 11:56:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL. THERE WAS NO PUMP ERROR 43 THE EVENT DATE 05-JAN-2023. HOWEVER, THERE WERE PUMP ERROR 43 NOTED BELOW: 10/30/2022 00:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) 11/04/2022 13:41:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION. PUMP ERROR 43 WAS CONFIRMED IN THE PUMP HISTORY FILE DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE MOTOR AND FORCE SENSOR HAD MOISTURE DAMAGE. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED DKA/HIGH BGS. INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS NOT CONFIRMED. PUMP ERROR 43 WAS 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 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

    (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. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 580 MG/DL AT THE TIME OF THE EVENT AND REPORTED A PUMP ERROR 43. THE CUSTOMER ALSO RECEIVED AN INSULIN FLOW BLOCK. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS DIABETIC KETOACIDOSIS, FEELING SICK, UNWELL, TIRED, AND WEAK. THE CUSTOMER WAS HOSPITALIZED AND TREATED WITH AN INTRAVENOUS DRIP. THE CUSTOMER IS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN FLOW BLOCK WAS RESOLVED BY COMPLETE SET CHANGE. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY AND STATED THAT THE PUMP REWIND WAS COMPLETED. ADVISED THE CUSTOMER TO DO A DISPLACEMENT AND SELF TEST ON THE PUMP AND IT GOT PASSED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129652 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 HG4YRJRZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET