BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143334 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30160
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    CUSTOMER'S MOTHER REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 400 MG/DL. SHE WAS NOT IN AN ACCIDENT. CUSTOMER'S MOTHER STATED THAT THEY WERE NEW TO THE INSULIN PUMP AND WERE HAVING DIFFICULTY TELLING IF INSULIN WAS BEING DELIVERED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603475 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization