BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3894851 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03389
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 CALLER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR OBSERVATIONS OF HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE OF THE CUSTOMER AT THE TIME OF THE HOSPITALIZATION WAS ABOVE 300 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370494 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization