BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19899116 · Received August 2, 2024

    Report

    Report Number
    2032227-2024-214700
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. CUSTOMER RETURNED PUMP FOR AN ALLEGED PRIME/FILL ANOMALY AND WAS HOSPITALIZED FOR HIGH BGS/DKA FOUND ON (B)(6) 2024 (PER SS EVENT DATE). HOWEVER, AS PER CUSTOMER'S NOTE: CUSTOMER RETURNED PUMP FOR AN ALLEGED PRIME/FILL ANOMALY AND WAS HOSPITALIZED FOR HIGH BGS/DKA FOUND ON (B)(6) 2024. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO VERIFY PRIME/FILL ANOMALY AND PERFORM 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 DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE SS EVENT DATE OF 11-JUL-2024 AND CUSTOMER'S EVENT DATE OF 08-JUL-2024, THERE WERE NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE SS EVENT DATE OF 11-JUL-2024 AND CUSTOMER'S EVENT DATE OF 08-JUL-2024 LISTED ON SMARTSOLVE. DAILY TOTAL COLLECTION START TIME: ON (B)(6) 2024 00:00:00.000. DAILY TOTAL OF ALLIN SULIN DELIVERED: 890250 (89.025 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 291250 (29.125 U). DAILY TOTAL OF BOLUS INSULIN DELIVERED: 599000 (59.9 U). DAILY TOTAL COLLECTION STARTTIME: ON (B)(6) 2024 00:00:00.000. DAILY TOTAL OF ALL INSULIN DELIVERED: 470500 (47.05 U) DAILY TOTAL OF BASAL INSULIN DELIVERED: 301000 (30.1 U) DAILY TOTAL OF BOLUS INSULIN DELIVERED: 169500 (16.95 U) THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE SS EVENT DATE OF 11-JUL-2024 AND CUSTOMER'S EVENT DATE OF 08-JUL-2024 IN THE FORMATTED HISTORY FILE. HOWEVER, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 55 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6) 2024 07:45:51.000 AND (B)(6) 2024 07:55:00.000. AS PER GLOBAL LOGIC ANALYSIS (ESF (B)(4), PUMP ERROR 55 ALARM (LINE NUMBER 645 FILE NUMBER 39), SUSPECTED ON HW.PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.16 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. UNABLE TO VERIFY PRIME/FILL ANOMALY, PERFORM THE REQUIRED TESTING, UPLOAD PUMP TO CARELINK DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 55. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 55 ALARM CONFIRMED, SUSPECTED ON HW. 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 DELIVERY/OCCLUSION ALARM. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 1190 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, DIABETIC KETOACIDOSIS, MALAISE, LOSS OF CONSCIOUSNESS TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), EMS/AMBULANCE/ER VISIT, HOSPITALIZATION: OVERNIGHT STAY. CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: TROUBLESHOOTING WAS PERFORMED FOR THE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880, MMT-399A, MMT-332A. CUSTOMER WAS NOT USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. CUSTOMER REPORTED HIGH BGS. CUSTOMER HAS NOT BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED HIGH BG EVENT. CUSTOMER REPORTED RECEIVING A REWIND REQUEST AFTER AN ALARM OR BEING UNABLE TO EXIT LOAD RESERVOIR PROCESS. CUSTOMER COMPLETED REWIND AND LOAD RESERVOIR PROCESS SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-399A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398978 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 NG3305643H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other| H| R FRN-MMT-332A-RSVR, UNOMED SET