BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20911103 · Received December 12, 2024

    Report

    Report Number
    2032227-2024-284366
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 17, 2024
    Report Date
    January 8, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08720 INCHES. THE PUMP WAS MONITORED AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 17-NOV-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 17-NOV-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 11/17/2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 542750 (54.275 U) DAILYTOTALOFBASALINSULINDELIVERED: 263750 (26.375 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 279000 (27.9 U) THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 17-NOV-2024 IN THE FORMATTED HISTORY FILE. 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. LOW BATTERY ALERT WAS FOUND ON: 11/17/2024 02:29:00.000 INSERT BATTERY ALARM WAS FOUND ON: 11/17/2024 11:13:13.000, 11/17/2024 11:13:14.000 11/17/2024 11:13:16.000, 11/17/2024 11:13:17.000 11/17/2024 11:13:19.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 11/17/2024 11:13:13.000, 11/17/2024 11:13:16.000 11/17/2024 11:13:19.000 INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A LOW/NO POWER BATTERY. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.48 MV). THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE TEST P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT; HOWEVER, A CRACKED RESERVOIR TUBE LIP AND A PARTIALLY BROKEN RETAINER WERE WAS NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY A KEYPAD OVERLAY TEXTURE DAMAGE, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A BROKEN BELT CLIP RAILS. CUSTOMER ALLEGED FOR BLANK DISPLAY WAS NOT CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. RETAINER RING DAMAGE (A CRACKED RESERVOIR TUBE LIP AND A PARTIALLY BROKEN RETAINER) WAS CONFIRMED. 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.

    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 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

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED NO ALLEGED DEVICE DEFICIENCY. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 470 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, ELEVATED KETONES/DIABETIC KETOACIDOSIS, MALAISE, DIAPHORETIC, HEADACHE, PAIN, CONFUSION/DISORIENTATION TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), EMS/AMBULANCE/ER VISIT, IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), EMS/AMBULANCE/ER VISIT, IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION). CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: DKA DOCUMENT TREATMENT FOR HIGH BG: INSULIN DRIP ADMITTED TO ICU OTHER THAN INSULIN, INDICATE MEDICATIONS TAKEN TO TREAT DIABETES: INSULIN DOCUMENT TYPE OF DIABETES: TYPE1. THE EVENT INVOLVED PRODUCT(S) MMT-397A, MMT-332A, MMT-1880. CUSTOMER WAS NOT USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. HIGH BGS/UNDER DELIVERY. CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202845 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 HG5B4J4ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other| R FRN-MMT-332A-RSVR, UNOMED SET.