BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20385489 · Received October 7, 2024

    Report

    Report Number
    2032227-2024-249598
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 14, 2024
    Report Date
    November 14, 2024
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 0.08735 INCHES. 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 (B)(6) 2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW, FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF (B)(6) 2024, LISTED ON SMARTSOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED: 21500 (2.15 U); DAILY TOTAL OF BASAL INSULIN DELIVERED: 21500 (2.15 U); DAILY TOTAL OF BOLUS INSULIN DELIVERED: 0 (0 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. PLEASE SEE BELOW, FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK, PRIOR TO THE EVENT DATE (B)(6) 2024, IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS FOUND ON: 09/14/2024, 03:39:36.000; 09/14/2024, 03:49:00.000. PUMP ERROR 23 ALARM WAS FOUND ON: 09/14/2024, 03:50:04.000. POWER LOSS ALARM WAS FOUND ON: 09/14/2024, 03:52:27.000; 09/14/2024, 03:52:35.000. 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. INSERT BATTERY ALARM WAS EXPECTED, SINCE THE BATTERY WAS REMOVED FROM THE PUMP. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED, SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED, DURING TESTING. 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 PROCELL CONSTANT ALKALINE BATTERY INSTALLED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT, DURING TESTING. THE FOLLOWING WERE NOTED, DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP PASSED, ALL THE REQUIRED TESTING. UNABLE TO VERIFY, CUSTOMER ALLEGED FOR HIGH BGS/DKA. 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 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 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 HARM REPORTED WITH NO REPORTED ALLEGATION OF A DEVICE MALFUNCTION. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 1200 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, ELEVATED KETONES/DIABETIC KETOACIDOSIS, CONFUSION/DISORIENTATION, MALAISE TREATED WITH MANUAL INJECTION/INSULIN PEN, IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION), EMS/AMBULANCE/ER VISIT, HOSPITALIZATION: OVERNIGHT STAY. THE EVENT INVOLVED PRODUCT(S) MMT-397, MMT-332A, MMT-1880. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BG EVENT. THE CUSTOMER WAS NOT USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. MMT-1880 WAS REQUESTED, AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213581 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 NG3234853H 000000763000640095

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization| R FRN-MMT-332A-RSVR, UNOMED INF SET