BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G

    MDR report key: 7686908 · Received July 13, 2018

    Report

    Report Number
    2032227-2018-08216
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 14, 2018
    Report Date
    July 13, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AS WELL AS LOW BLOOD GLUCOSE LEVEL. CUSTOMER EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL WAS 189, 230, 148, 158, 48, 38, 90, 50,259MG/DL. TROUBLESHOOT WAS NOT PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526718 PUMP MMT-1780KPK 670G ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other