BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16859031 · Received May 3, 2023

    Report

    Report Number
    2032227-2023-201983
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    February 16, 2023
    Report Date
    May 30, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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.

    Additional Manufacturer Narrative · 0

    S/W 5.2A. RETAINER RING = BLACK. CASE TYPE = NGP. ON (B)(6) -2023, THE CUSTOMER ALLEGED WAS NOT DELIVERING INSULIN, UNEXPECTED BATTERY POWER LOSS, THE CUSTOMER EXPERIENCED DKA, PUMP UNDER DELIVERY AND EMERGENCY ROOM FOR HIGH BG. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. PUMP RECEIVED WITH CRACKED SELECT BUTTON KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, SERIAL NUMBER LABEL MISSING AND CRACKED CASE NEAR THE CORNER OF BELT CLIP RAILS DURING THE VISUAL INSPECTION. THUMP AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW OF THE PUMP HISTORY ON THE EVENT DATE OF (B)(6) 2023 THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND MULTIPLE BOLUS DELIVERIES THAT THE CUSTOMER MANUALLY PROGRAMMED AND THE DAILY TOTAL OF BOLUS INSULIN DELIVERED ARE 31.8 U. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND: LOW BATTERY ALARMS ON (B)(6) 2023 AT 03:20:00.000 REPLACE BATTERY ALERT ON (B)(6) 2023 AT 12:53:00.000 FAILED BATT/BATTERY FAILED ALARM ON (B)(6) 2023 AT 12:59:06.000 MULTIPLE INSULIN FLOW BLOCKED/NO DELIVERY ALARM ON (B)(6) 2023 FROM 12:24:08 UNTIL 14:06:21 DURING BOLUS AND BASAL DELIVERY. PUMP PASSED 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 DAT AT 0.08710 INCHES. NO ¿NO DELIVERY ALARM¿ OR UNEXPECTED BATTERY POWER LOSS DURING TESTING. PUMP PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL REGISTERED PROPERLY RECORDED IN THE DAILY HISTORY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE FORCE SENSOR OFFSET MEASURED WITHIN SPEC RANGE DURING TESTING (23.3 MV). IN SUMMARY, PUMP PASSED ALL REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BG AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION. CUSTOMER ALLEGED NOT CONFIRMED FOR NOT DELIVERING INSULIN, PUMP UNDER DELIVERY AND UNEXPECTED BATTERY POWER LOSS. 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 REPORTED THAT THE INSULIN HAD NOT WORKING AND NOT DELIVERING INSULIN AND THE CUSTOMER EXPERIENCED DIABETIC KETOACIDOSIS AND HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 479 MG/DL AT THE TIME OF THE EVENT. THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION/INSULIN PEN AND USING DEXCOM CONTINUOUS GLUCOSE MONITOR. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND HAD HIGH KETONES AND WAS TREATED WITH INTRAVENOUS LIQUIDS AND INTRAVENOUS DRIP. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. THE AUTO MODE/SMARTGUARD FEATURE WAS NOT ACTIVE AT THE TIME OF THE HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER ALLEGED THE PUMP WAS UNDER-DELIVERING AS THE CUSTOMER HAD NOT GOTTEN ANY INSULIN ACCORDING TO THE BLOOD GLUCOSE RISING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER DISCONTINUED USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246501 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 HG5G901ZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention| O FRN-MMT-332A-RSVR, UNOMED-INF SET, OZP-MMT-7020LA-