BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8154330 · Received December 12, 2018

    Report

    Report Number
    2032227-2018-73842
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 12, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HIGH AND LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 42 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 70 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE LEVELS WERE 241, 232, 418 MG/DL. THE CUSTOMER TREATED WITH APPLE JUICE AND FOOD. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER¿S REPORT CUSTOMER DOES NOT ALLEGE OVER DELIVERY. THE CUSTOMER WAS WEARING THE INSULIN PUMP WHEN HIGH BLOOD GLUCOSE EVENT WAS REPORTED. CUSTOMER NOT USING AUTO MODE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996509 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG27CNA 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other FRN-UNK-RSVR, UNOMED SET