BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19005246 · Received March 29, 2024

    Report

    Report Number
    2032227-2024-148635
    Event Type
    Death
    Date Received
    March 29, 2024
    Date of Event
    December 15, 2021
    Report Date
    March 29, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08660 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS NOTED DURING THE TESTING. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE (B)(6) 2021. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 18:43:00.000 REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:14:00.000, (B)(6) 2021 04:24:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:45:00.000, (B)(6) 2021 04:55:00.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:56:03.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:56:17.000, (B)(6) 2021 04:56:25.000. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE EXPECTED SINCE THE BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. POWER LOSS ALARM WAS EXPECTED SINCE THE PUMP RESET DUE TO BATTERY BACKUP DEPLETION. 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 ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM), SUSPECTED ON THE PCBA 1. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2021 IN THE FORMATTED HISTORY FILE. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITH A DEPLETED ENERGIZER INDUSTRIAL ALKALINE BATTERY INSTALLED. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2021. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE DATE OF (B)(6) 2021 LISTED ON PUMP HISTORY AND THE DAYS PRIOR TO THAT DATE. (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 176750 (17.675 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); (B)(6) 2021, DAILYTOTALOFALLINSULINDELIVERED: 0 (0 U); THERE IS NO AVAILABLE DATA AFTER (B)(6) 2021. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND LOW BGS. A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM) WAS CONFIRMED, SUSPECTED ON THE PCBA 1. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT PATIENT PASSED AWAY AT HOSPITAL ON (B)(6) 2021 DUE TO DIABETES COMPLICATIONS/ INTERNAL BLEEDING. CUSTOMER WAS HOSPITALIZED BLOOD GLUCOSE VALUE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT INSULIN PUMP WAS NOT WORN AT TIME OF PASSING. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS. FRN-MMT-332-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583678 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 HG4ZSELZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death| R| H| O