BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7046154 · Received November 20, 2017

    Report

    Report Number
    2032227-2017-67057
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    July 7, 2017
    Report Date
    November 20, 2017
    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

    IT WAS REPORTED VIA E-MAIL THAT CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE WAS 40 MG/DL ON (B)(6) 2017, 35 MG/DL ON (B)(6) 2017 AND BLOOD GLUCOSE OF 60 MG/DL WHICH WENT UP TO 78 MG/DL . THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823768 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG1VG0D 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other