BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8743620 · Received June 28, 2019

    Report

    Report Number
    2032227-2019-22747
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 22, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    "CUSTOMER REPORTED VIA PHONE CALL THAT THE RED X ON THE HOME SCREEN OF THE PUMP." THE BLOOD GLUCOSE LEVEL WAS 274 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED FOR CRITICAL PUMP ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539901 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG31Z4G 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR