BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 9265571 · Received November 1, 2019

    Report

    Report Number
    2032227-2019-112366
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 22, 2019
    Report Date
    November 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE DOWN AND LEFT ARROW BUTTONS WERE NOT WORKING PROPERLY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THERE WAS A LAG OR DELAY WHEREIN SHE HSD TO PRESS THE BUTTON FOR 4-6 TIMES BEFORE THE INSULIN PUMP RESPONDED. THE CUSTOMER STATED THAT THERE WAS INTERMITTENT RESPONSE FOR A WHILE IN THE LAST COUPLE OF MONTHS BUT THESE PAST COUPLE OF DAYS, THE BUTTONS WERE NOT RESPONDING IMMEDIATELY. CUSTOMER STATED THAT NUMBERS WERE NOT RAMPING ON THEIR OWN. CUSTOMER STATED THE SCROLL BAR WAS NOT MOVING WITH NO INPUT. CUSTOMER STATED PRESSING MENU BUTTON TOOK THEM TO THE MENU SCREEN. CUSTOMER STATED USING THE UP ARROW ALLOWED THEM TO NAVIGATE SCREENS. CUSTOMER STATED USING THE DOWN ARROW ALLOWED THEM TO NAVIGATE SCREENS. CUSTOMER STATED THE INSULIN PUMP WAS NEITHER DROPPED NOR EXPOSED TO MOISTURE. CUSTOMER STATES THE BUTTONS ARE RESPONDING NOW. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061919 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG1YSKP 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR