BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8930116 · Received August 26, 2019

    Report

    Report Number
    2032227-2019-52923
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    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 CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 600, 102, 390 MG/DL. THE CUSTOMER STATED THAT THERE WAS SOMETHING IS WRONG WITH THE INSULIN PUMP. IT WAS REPORTED THAT THEY WILL CALL BACK WHEN SHE HAS MORE TIME TO PERFORM TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726348 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG37ZL8 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other FRN-UNKNOWN-RSVR, UNOMEDICAL SET