BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 14652168 · Received June 10, 2022

    Report

    Report Number
    2032227-2022-208962
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    September 25, 2021
    Report Date
    June 10, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON (B)(6) 2021 THE CUSTOMER REPORTED THAT SHE DOESN'T GET MICRO-BOLUSES WHILE USING SMARTGUARD. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. UNIT PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS; IT FAILED REWIND TEST. DURING MOTOR REWIND, THE UNIT RETURNED A NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED. UNABLE TO PERFORM THE DISPLACEMENT PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR AND OCCLUSION TESTS DUE TO THE RECURRING NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED. UNABLE TO INITIATE SMART GUARD BECAUSE THE DELIVERY IS SUSPENDED DUE TO THE NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, THERE IS CORROSION ON THE HOME MOTOR SWITCH, AND THE RUBBER STOPPER OF THE MOTOR SLIDE IS MISSING. DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION INSIDE THE BATTERY COMPARTMENT, BATTERY BOARD, OR ON ANY OF THE OTHER BOARDS AND ASSEMBLIES INSIDE THE UNIT. IN SUMMARY, THE CUSTOMER¿S REPORT THAT SHE DOESN'T GET MICRO-BOLUSES WHILE USING SMARTGUARD WAS UNABLE TO BE CONFIRMED DURING TESTING DUE TO THE NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED. THE NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED IS DUE TO A CORRODED HOME MOTOR SWITCH. (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED SMART GUARD DID NOT CONTAIN MICRO BOLUSES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387748 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 000000763000384258

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown