BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5891394 · Received August 19, 2016

    Report

    Report Number
    3004209178-2016-70361
    Event Type
    Injury
    Date Received
    August 19, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 31, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE OF 550MG/DL. THE CUSTOMER WAS ADVISED TO CHANGE OUT ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER DOCTOR'S INSTRUCTION. CUSTOMER WAS ADVISED TO CONTACT THEIR DOCTOR REGARDING THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO CALL BACK IF FURTHER ASSISTANCE IS NEEDED AND AFTER THEY CALL THEIR DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543574 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other