BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7294663 · Received February 24, 2018

    Report

    Report Number
    3004209178-2018-52977
    Event Type
    Injury
    Date Received
    February 24, 2018
    Date of Event
    February 5, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW AND HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS DECLINING TO 44 MG/DL AND RISING TO 266 MG/DL. THE CUSTOMER¿S OTHER BLOOD GLUCOSE VALUES ARE 142, 355, 142, 103, 180, 203, 139, 143, 114, 316, 287, 63, 56, AND 69 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE IS 151 MG/DL. THE CUSTOMER WAS TREATED HER LOWS WITH THE GLUCOSE TABLETS AND HIGHS WITH THE PUMP. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOM AS A RESULT OF LOW OR HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED FOR LOW AND HIGH BLOOD GLUCOSE AND OVER AND UNDER DELIVERY RESPECTIVELY HOWEVER, THE CUSTOMER DECLINED TROUBLESHOOT FOR LOW AND HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137516 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG236MD 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other