BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8681890 · Received June 10, 2019

    Report

    Report Number
    2032227-2019-13646
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    February 14, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 1000 MG/DL. THE CUSTOMER EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL OF 69 MG/DL AND 498 MG/DL. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN AND INTRAVENOUS FLUIDS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS WEARING THE INSULIN PUMP WITHIN 48 HOURS DURING THE HOSPITALIZATION. THE CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477954 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2F4F6 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization FRN-UNK-RSVR,UNOMED SET