BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 11736205 · Received April 28, 2021

    Report

    Report Number
    2032227-2021-139879
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 23, 2021
    Report Date
    April 28, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000090203
    Adverse Event
    Yes
    Product Problem
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE WAS 250-253 MG/DL. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. CUSTOMER STATED THAT THE AUDIO IS NOT WORKING. THEY DID NOT HEAR THE BEEPS WHEN AUDIO VOLUME SETTINGS WERE SAVED. CUSTOMER REPORTED THAT THE AUTO MODE WAS ACTIVE DURING THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633571 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2KVHU 000000763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other FRN-MMT-332A, UNOMEDMMT-864A, OZO-7020A