BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1710K

    MDR report key: 11964499 · Received June 9, 2021

    Report

    Report Number
    2032227-2021-154337
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 29, 2021
    Report Date
    October 18, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169746862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE DOWNLOADED HISTORY/TRACE FILE PROPERLY USING THUS. DEVICE PASSED DISPLACEMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPECIFIC RANGE. NO UNEXPECTED BLANK DISPLAY, LOW BATTERY, FAILED BATTERY TEST OR POWER LOSS ERRORS WERE NOTED DURING TESTING OR IN FILE HISTORY ON THE DAY (B)(6) 2021. HOWEVER, INSULIN PUMP RECEIVED WITH A HIGH SLEEP CURRENT MEASUREMENT DURING TESTING. ALSO, MOISTURE/DAMAGE FOUND ON THE ELECTRICAL BOARD 1, INTERNAL BATTERY CONNECTOR, BATTERY CONNECTOR DURING VISUAL INSPECTION. THE ORIGINAL ELECTRICAL BOARD 1 WAS REPLACED AND INSTALLED IN A TEST ELECTRICAL BOARD 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE INSULIN PUMP ON USING THE BATTERY SIMULATOR AND THE SLEEP CURRENT MEASUREMENT IS WITHIN SPECIFIC RANGE. IN CONCLUSION, INSULIN PUMP RECEIVED WITH A HIGH SLEEP CURRENT MEASUREMENT DUE TO MOISTURE DAMAGE ELECTRICAL BOARD 1. DEVICE HAD CRACKED KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS, CRACKED CASE CORNER OF BELT CLIP RAILS, LABEL DAMAGE. THE DEVICE P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY AND NO ANOMALY NOTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 620G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WOULD NOT COME BACK ON AFTER CUSTOMER WENT INTO THE LAKE AFTER WHICH INSULIN PUMP ALARMED AND TURNED OFF INDICATING BLANK DISPLAY. CUSTOMER ALSO REPORTED CRACK ON THE BATTERY COMPARTMENT. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868418 640G INSULIN PUMP MMT-1710K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1710K HG2JQDT 000000643169746862

    Patients

    Seq Age Sex Outcome Treatment
    1