BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8411233 · Received March 12, 2019

    Report

    Report Number
    3004209178-2019-66228
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    October 30, 2018
    Report Date
    March 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAILED BATT TEST ALARMS NOTED DURING TESTING. UNIT PASSED DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELFTEST. TOGGLED ON/OFF AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO/VIBRATE/ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING. PUMP ERROR 54 WAS PRESENT IN THE PUMP TRACE DOWNLOAD DUE TO SOFTWARE ERROR (ESF 3010978). PUMP ERROR WAS PRESENT IN THE PUMP TRACE DOWNLOAD, PROBLEM ISOLATED TO ELECTRONIC BOARD STACK.

    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 UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER RECEIVED REQUEST TO REWIND.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 EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205302 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2K1KX 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR