BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OYC

    MDR report key: 9195624 · Received October 16, 2019

    Report

    Report Number
    2032227-2019-104196
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    October 11, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON ARE SOMETIMES NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991812 OYC PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR