BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 16224127 · Received January 23, 2023

    Report

    Report Number
    2032227-2023-135870
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    November 16, 2022
    Report Date
    January 23, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE UNIT WAS ABLE TO PASS THE FOLLOWING TESTS: DISPLACEMENT TEST AND SELF-TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. NO PUMP ERROR 54 & PUMP ERROR 3 OCCURRED DURING TESTING. PUMP ERROR 54 & PUMP ERROR 3 WERE PRESENT IN HISTORY DOWNLOAD ON EVENT DATE OF (B)(6) 2022 07:35 AM. ESF# 3010978, FILE NUMBER=2022, LINE NUMBER= 2803. P-CAP WAS TESTED AND LOCKED INTO PLACE PROPERLY. PUMP WAS CUT TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE FOLLOWING: ELECTRONIC ASSEMBLY & FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED CASE, BATTERY TUBE THREADS CRACKED, CRACKED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF BELT CLIP RAILS, CRACKED CASE (BATTERY TUBE), FADING SERIAL LABEL, KEYPAD OVERLAY TEXTURE DAMAGE. PUMP ERROR 54 & PUMP ERROR 3 WAS CONFIRMED DUE TO SOFTWARE DEFECT. ADDITIONAL COSMETIC DAMAGE WAS NOTED ON UNIT. 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 ERROR 3 AND PUMP ERROR 54. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND THE INSULIN PUMP. DISPLACEMENT TEST WAS PERFORMED AND IT WAS PASSED. 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
    616920 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5K7GN 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male