BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8516924 · Received April 16, 2019

    Report

    Report Number
    3004209178-2019-81874
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 30, 2019
    Report Date
    April 15, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 420 MG/DL. CUSTOMER ALSO HAD BLOOD GLUCOSE OF 251, 170 AND 80 MG/DL. THE CUSTOMER DID NOT PROVIDE THE SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED THAT THEY RECEIVED CHANGE SENSOR ALARM AND CALIBRATION OT ACCEPTED ALARM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311371 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG29KS3 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR UNOMED INFSET, FRN-RSVR, OZP-MMT-7020