BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885161 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03196
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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'S DOCTOR REPORTED THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS 868 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 149 MG/DL. CUSTOMER REPORTED ABDOMINAL PAIN, NAUSEA AND VOMITING PRIOR TO THE HOSPITALIZATION. AT THE HOSPITAL THE CUSTOMER WAS TREATED WITH INSULIN, POTASSIUM CHLORIDE AND BY CARB DRIPS. THROUGH TROUBLESHOOTING AIR BUBBLES WERE NOTED IN THE TUBING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360998 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization