BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20664651 · Received November 12, 2024

    Report

    Report Number
    2032227-2024-267631
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 17, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000640095
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE ACTIVE CURRENT TEST, AND SELF-TEST. UNIT FAILED TO PASS THE SLEEP CURRENT MEASUREMENT DUE TO HIGH CURRENTS. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH), AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. CUSTOMER EXPERIENCED AN UNEXPECTED BATTERY LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. LOW BATTERY OCCURRED ON (B)(6) 202418:07 & (B)(6) 2024 09:23 IN HISTORY FILE. REPLACE BATTERY ALERT OCCURRED ON (B)(6) 2024 23:02 & (B)(6) 2024 19:49 IN HISTORY FILES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY. CHARGE/BATTERY LASTS LESS THAN EXPECTED AND UNEXPECTED BATTERY POWER LOSS IS CONFIRMED AND ISOLATED TO THE ELECTRONIC STACK. NO CURRENT CODE IS CONFIRMED DUE TO RECEIVING UNIT WITH HIGH CURRENT AND ITS ISOLATED TO THE ELECTRONIC STACK. 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 CHARGE/BATTERY LASTS LESS THAN EXPECTED, AND UNEXPECTED BATTERY POWER LOSS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED RECEIVING A REPLACE BATTERY ALERT/ REPLACE BATTERY NOW ALARM. THIS WAS THE SECOND OCCURRENCE OF RECEIVING A REPLACE BATTERY ALERT WITHOUT RECEIVING A LOW BATTERY WARNING FIRST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1880 WAS REQUESTED AND CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514541 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 NG3291169H 000000763000640095

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male