BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183493 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40228
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    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. (B)(4)

    Description of Event or Problem · 1

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED GETTING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE CUSTOMER CLAIMED THAT IT WAS NOT DUE TO ANY INSULIN PUMP ISSUE BUT WAS DUE TO UNFAMILIARITY WITH THE WEATHER IN (B)(6). THE CUSTOMER ALSO REPORTED HAVING ISSUES WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663937 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR