BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8295550 · Received February 1, 2019

    Report

    Report Number
    3004209178-2019-50039
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    October 7, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED THE REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, SELF TEST AND DISPLACEMENT TEST. NO UNEXPECTED MOTOR ERROR ALARM OR HARDWARE LOW LEVEL FAILURE ALERT ALARM NOTED DURING TESTING. HOWEVER, HARDWARE LOW LEVEL FAILURE ALERT ALARM (VARIABLEI NFO=3) CONFIRMED IN THE PUMP HISTORY DUE TO BROKEN TRACE ON U1 KEYPAD ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURES ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 132 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89933 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG25TVM 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR