BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 10156854 · Received June 16, 2020

    Report

    Report Number
    2032227-2020-131318
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 16, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000166519
    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

    CUSTOMER REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE VIA INSULIN PUMP. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 350 MG/DL. CUSTOMER ADVISED THE PLASTIC ON THE INSULIN PUMP WAS ON THE SIDE. CUSTOMER WAS ADVISED TO CHANGE OUT THEIR ENTIRE INFUSION SET, RESERVOIR, INSULIN AND TREAT THEIR BLOOD GLUCOSE VIA HEALTHCARE PROVIDER'S INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623128 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG3QX51 00763000166519

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other FRN-UNK-RSVR UNOMED SET