BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100781 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93257
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 HAD UNEXPLAINED HIGH BLOOD GLUCOSE, DKA AND WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 439 MG/DL. CALLER STATED THAT THE CUSTOMER HAD A STREP THROAT AND DEHYDRATION PRIOR TO GOING TO THE HOSPITAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200614 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization