BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 7729436 · Received July 28, 2018

    Report

    Report Number
    3004209178-2018-96691
    Event Type
    Injury
    Date Received
    July 28, 2018
    Date of Event
    June 12, 2018
    Report Date
    July 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 WENT TO HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER'S EXPERIENCED DIFFERENT BLOOD GLUCOSE VALUES WERE 38, 129, 211, 177, 253, 245, 120, 68, 213 MG/DL. CUSTOMER WAS TREATED WITH BOLUS. TROUBLESHOOTING WAS DONE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571259 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG29570 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other