BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OYC

    MDR report key: 6128926 · Received November 28, 2016

    Report

    Report Number
    2032227-2016-46075
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT METER WAS NOT READING CORRECTLY. CUSTOMER REPORTED THAT CUSTOMER'S BLOOD GLUCOSE WAS 41 MG/DL AND METER WAS SHOWING A BLOOD GLUCOSE OF 599 MG/DL. CUSTOMER WAS GOING TO BE TAKEN TO THE EMERGENCY ROOM DUE TO NOT BEING ABLE TO SPEAK AND SOUNDING CONFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780415 OYC INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other