BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8665320 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-10812
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 11, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 CLINICAL TRIALS COORDINATOR REPORTED VIA PHONE CALL THAT THE MALE SUBJECT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 407 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462402 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2DJYB 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other UNOMED INF SET, FRN-UNK-RSVR