BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142072 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33396
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER STATED HE CALLED MONDAY BECAUSE THE DEVICE WAS GIVING A NO DELIVERY. CUSTOMER STATED HE CHANGED OUT THE ENTIRE SET BECAUSE HE THOUGHT THE INFUSION SET MIGHT BE KINKED AND THE FOLLOWING DAY THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OVER 600 MG/DL. CUSTOMER STATED PROBABLY THE BENT CANNULAS WERE WHAT LET TO THE DIABETICS KETOACIDOSIS. CUSTOMER WAS WEARING THE DEVICE AT THE TIME OF HOSPITALIZATION. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621231 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization