BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7970545 · Received October 16, 2018

    Report

    Report Number
    2032227-2018-43691
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 54 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS NOT ADMITTED INTO THE HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER DID NOT EXPERIENCES ANY SYMPTOMS RELATED TO THE LOW BLOOD GLUCOSE. CUSTOMER WAS TREATED WITH THE GLUCOSE . THE INSULIN PUMP WILL NOT L BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811495 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG284EA 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other FRN MODEL UNKNOWN, UNOMEDICAL - INFUSION SET