BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8825250 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-35762
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 6, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 440 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THERE WAS SOMETHING INSIDE THE TRANSMITTER CONNECTOR BRIDGE THAT WAS PREVENTING IT FROM PROPERLY CONNECTING TO ANY SENSOR. IT WAS REPORTED THAT THERE MAY BE DAMAGE TO THE CONNECTOR PINS AND COULD NOT ATTACHED TRANSMITTER TO ANY OF THE SENSORS. THE CUSTOMER COULD NOT HEAR AN AUDIBLE SNAP/CLICK WHEN THEY TRIED TO CONNECT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618789 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other FRN- UNK-RSVR, UNOMED INF SET