BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8284691 · Received January 29, 2019

    Report

    Report Number
    3004209178-2019-48844
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 13, 2019
    Report Date
    January 29, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED THE HYPERGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 483 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL ARE 304, 117, 94, 87, 142, 483, 519, 456, 462, 268, 155, 403, 225, 132, 360, 370, 361, 189, 175, 399, 222, 127 MG/DL. THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80259 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2ZVDT 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other OZP-MMT-7020-SNSR, FRN-UNK-RSVR, UNOMED SET