BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841721 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02620
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    CUSTOMER REPORTED THAT SHE HAD TO CALL THE PARAMEDICS AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 500 MG/DL. CUSTOMER COMPLAINED ABOUT HAVING EXPERIENCED DIABETIC KETOACIDOSIS. THE SYMPTOMS WERE VOMITING, SHORTNESS OF BREATH AND TIGHTNESS AROUND HER NECK. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EVENT. SHE WAS TREATED IN THE HOSPITAL AND DISCHARGED TWO DAYS LATER. CURRENT BLOOD GLUCOSE READING IS 130 MG/DL . NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318827 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization