BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4251619 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-33275
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS REALLY SICK WITH DIARRHEA. IT WAS STATED THAT THE CUSTOMER DID NOT WANT TO BE ON INSULIN PUMP THERAPY AT THE TIME. IT WAS STATED THAT THE CUSTOMER HAD TO BE TAKEN TO THE HOSPITAL AND WANTED TO DISCONNECT AND STORE THE INSULIN PUMP UNTIL THE CUSTOMER FELT WELL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736345 INSULIN INFUSION PUMP OZO OZO MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention