BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17981789 · Received October 21, 2023

    Report

    Report Number
    2032227-2023-287777
    Event Type
    Injury
    Date Received
    October 21, 2023
    Date of Event
    September 25, 2023
    Report Date
    October 21, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000640095
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    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. 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 0.0871 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. 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 WAS RECEIVED WITH A DEPLETED ENERGIZER MAX ALKALINE BATTERY INSTALLED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. THERE WERE NO BOLUSES LISTED ON THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE ON THE PRIMARY SVN (B)(4). PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE (B)(6) 2023 ON THE PRIMARY SVN (B)(4). (B)(6) 2023 00:00:00.000 DAILYTOTALSG670 (63) DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 234000 (23.4 U) DAILYTOTALOFBASALINSULINDELIVERED: 234000 (23.4 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 0 (0 U) THERE WERE NO AUTOSUSPEND (12) ALARM OR USERSUSPENDED ALARM NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE ON THE PRIMARY SVN (B)(4). (B)(6) 2023 17:07:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) (B)(6) 2023 02:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: CHANGEBATTERYFAULT (73) (B)(6) 2023 02:48:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: CHANGEBATTERYFAULT (73) (B)(6) 2023 03:09:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: OFFNOPOWER (11) (B)(6) 2023 03:19:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: OFFNOPOWER (11) (B)(6) 2023 07:24:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6) 2023 12:08:47.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2023 9:54:57 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF(B)(6) 2023 AND (B)(6) 2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, AND REPLACE BATT ALERT/CHANGEBATTERYFAULT (73), AND REPLACE BATTERY NOW ALARM/ OFFNOPOWER (11) ALARM. 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. LOWBATTERYALERT (104) UNKNOWN. CHANGEBATTERYFAULT (73) UNKNOWN. OFFNOPOWER (11) UNKNOWN. NODELIVERY (7) ALARM NOT CONFIRMED. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATE(B)(6) 2023 IN THE PUMP HISTORY FILE ON SVN (B)(4). (B)(6) 2023 12:28:05.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 66000 (6.6 U) BOLUSAMOUNTDELIVERED: 66000 (6.6 U) (B)(6) 2023 17:13:35.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 75000 (7.5 U) BOLUSAMOUNTDELIVERED: 75000 (7.5 U) PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE (B)(6) 2023 ON SVN (B)(4). (B)(6) 2023 00:00:00.000 DAILYTOTALSG670 (63) DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2023 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 372500 (37.25 U). DAILYTOTALOFBASALINSULINDELIVERED: 231500 (23.15 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 141000 (14.1 U). THERE WERE NO AUTOSUSPEND (12) ALARM OR USERSUSPENDED ALARM NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE ON SVN (B)(4). (B)(6) 2023 17:07:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) (B)(6) 2023 02:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: CHANGEBATTERYFAULT (73) (B)(6) 2023 02:48:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: CHANGEBATTERYFAULT (73) (B)(6) 2023 03:09:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: OFFNOPOWER (11) (B)(6) 202303:19:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: OFFNOPOWER (11) (B)(6) 2023 07:24:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6) 202312:08:47.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2023 9:54:57 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF (B)(6) 2023AND (B)(6) 2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, AND REPLACE BATT ALERT/CHANGEBATTERYFAULT (73), AND REPLACE BATTERY NOW ALARM/ OFFNOPOWER (11) ALARM. 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. LOWBATTERYALERT (104) UNKNOWN. CHANGEBATTERYFAULT (73) UNKNOWN. OFFNOPOWER (11) UNKNOWN. NODELIVERY (7) ALARM NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS/DKA. 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 860 MG/DL. THE CUSTOMER REPORTED CONFUSION AND FEELING SICK AS SYMPTOMS. TROUBLESHOOTING WAS PERFORMED. IT WAS FOUND THAT THE CUSTOMER HAD TREATED THE HIGH BLOOD GLUCOSE EVENT WITH INTRAVENOUS INSULIN INFUSION. THE CUSTOMER HAD DIABETIC KETOACIDOSIS AND VISITED THE EMERGENCY MEDICAL SERVICE ADMITTED TO THE HOSPITAL. THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THE AUTO-MODE FEATURE WAS NOT ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996006 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 NG3262121H 000000763000640095

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization| R FRN-MMT-332A-RSVR, UNOMED SET, OZP-MMT-7020A-SNSR