BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15257941 · Received August 19, 2022

    Report

    Report Number
    2032227-2022-312527
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    March 10, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUMP¿S HISTORY AND TRACE FILES DOWNLOADED SUCCESSFULLY USING THUS SOFTWARE. UNIT PASSED THE SELF-TEST AND DISPLACEMENT TEST. NO PUMP ERROR ALARMS NOTED DURING TESTING. HOWEVER, THE HISTORY/TRACE DOWNLOAD CONFIRMED PUMP ERROR (LINE NUMBER 1421 FILE NUMBER 32122) ALARMS ON (B)(6) 2022 11:44:01. PUMP ERROR (LINE NUMBER 2803 FILE NUMBER 2002) ALARMS ON (B)(6) 2022 11:44:03. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND NO ALARMS NOTED DURING TESTING. TEST P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND CRACKED KEYPAD OVERLAY. PUMP ERROR (LINE NUMBER 1421 FILE NUMBER 32122) ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON (B)(6) 2022 11:44:01 DUE TO A SOFTWARE ANOMALY ((B)(4) ). PUMP ERROR ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON (B)(6) 2022 11:44:03 DUE TO SOFTWARE ERROR CONFIRMED IN PUMP ERROR. 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 INSULIN PUMP HAD PUMP ERRORS. CUSTOMER STATED THEY WERE KICKED OUT FROM AUTO MODE. CUSTOMER WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND. CUSTOMER STATED THEY HAD PASSED SELF TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2817894 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4YU6W 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female