BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8415851 · Received March 13, 2019

    Report

    Report Number
    3004209178-2019-67003
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    August 10, 2018
    Report Date
    March 13, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP ERROR CONFIRMED IN THE SELF TEST AND THE DOWNLOADED HISTORY LOG DUE TO A PIO (SOFTWARE) FAILURE. PUMP FAILED THE SLEEP CURRENT MEASUREMENT TEST. FAILURE HAS BEEN ISOLATED TO PCBA 1. UNIT PASSED THE ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, OCCLUSION, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MULTIPLE PUMP ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 121 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM(S). CUSTOMER STATES THEY ARE ABLE TO REWIND THE PUMP. SELF TEST PASSED THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210821 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2D3AF 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR