BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8806070 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32404
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 8, 2019
    Report Date
    September 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED BUTTON DOME SWITCHES. UNABLE TO PERFORM THE DISPLACEMENT TEST AND SELF TEST OR VERIFY PUMP ERROR 68 DUE TO UNRESPONSIVE BUTTONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP HAD RECEIVED STUCK BUTTON ALARM AND TRACE POINTERS INVALID ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 293 MG/DL. THE CUSTOMER WAS NOT ABLE TO CLEAR THE PUMP ERROR ALARM AS THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING FOR STUCK BUTTON ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. HE WAS ALSO ADVISED TO PUT THE INSULIN PUMP INTO STORAGE MODE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600049 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG349SS 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR