BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17206343 · Received June 27, 2023

    Report

    Report Number
    2032227-2023-225237
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 24, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 0.0872 INCHES. USING A TEST BATTERY CAP, THE PUMP POWERED UP PROPERLY AFTER THE TEST BATTERY WAS INSTALLED. NO BATTERY RELATED ALARMS OR BLANK DISPLAY NOTED AFTER THE PUMP POWERED UP. THE PUMP WAS PROGRAMMED AND MONITORED FOR 2 DAYS. NO BLANK DISPLAY NOTED DURING TESTING. 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 DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 06-JUN-2023 IN THE PUMP HISTORY FILE. ON (B)(6) 2023 13:14:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: LOST SENSOR 1 ALERT (780). ON (B)(6) 2023 13:24:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: LOST SENSOR 1 ALERT (780). ON (B)(6) 2023 01:43:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: LOST SENSOR 1 ALERT (780). ON (B)(6) 2023 02:02:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: LOST SENSOR 2 ALERT (781). ON (B)(6) 2023 02:12:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: LOST SENSOR 2 ALERT (781). ON (B)(6) 2023 16:03:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: LOW BATTERY ALERT (104). THE CUSTOMER'S BATTERY VOLTAGE IS 0.964 VOLTS. ON (B)(6) 2023 01:34:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: CHANGE BATTERY FAULT (73). ON (B)(6) 2023 02:05:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: OFF NO POWER (11). ON (B)(6) 2023 02:15:00.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: OFF NO POWER (11). ON (B)(6) 2023 02:16:04.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: POST RESET RAM CRC ALARM (23). ON (B)(6) 2023 02:17:08.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: BATT OUT LIMIT (6). ON (B)(6) 2023 02:17:16.000 ALARM ALERT NOTIFICATION (40). FAULT NUMBER: BATT OUT LIMIT (6). THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALARM NOTED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, BATT OUT LIMIT (6)/POWER LOSS ALARM, CHANGE BATTERY FAULT (73)/REPLACE BATTERY ALERT OR OFF NO POWER (11)/REPLACE BATTERY NOW ALARM NOTED DURING TESTING. LOW BATTERY ALERT WAS DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. THE TEST BATTERY WAS REMOVED AND REINSERT IN LESS THAN 1 MINUTE INTO THE BATTERY COMPARTMENT. NO UNEXPECTED PUMP ERROR 23 OR BATTERY OUT LIMIT ALARM NOTED DURING TESTING OR AFTER BATTERY CHANGE. LOST SENSOR 1 ALERT (780) NOT CONFIRMED. LOW BATTERY ALERT NOT CONFIRMED. CHANGE BATTERY FAULT (73) NOT CONFIRMED. OFF NO POWER (11) NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. BATT OUT LIMIT (6) NOT CONFIRMED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. 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. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 500 MG/DL. THE CUSTOMER REPORTED BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. IT WAS FOUND THAT THE CUSTOMER HAS TREATED THE HIGH BLOOD GLUCOSE EVENT WITH EMERGENCY MEDICAL SERVICE. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. UNKNOWN WHETHER THE AUTO-MODE FEATURE WAS ACTIVE OR NOT. 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
    841541 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 NG3383608H

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention FRN-MMT-342-RSVR, UNOMED INF SET.