BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3808189 · Received May 13, 2014

    Report

    Report Number
    2032227-2014-02351
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    June 15, 2012
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2014-002349, 2032227-2014-002350, 2032227-2014-002352.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2012 HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. THE BLOOD GLUCOSE READING WAS OVER 800 MG/DL. CUSTOMER STATED THAT THE HIGH BLOOD GLUCOSE MAY BE BECAUSE HE WAS NOT EATING THE RIGHT FOOD. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286590 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization