BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182782 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02548
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 21, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 65 MG/DL. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 661 MG/DL. CUSTOMER EXPERIENCED NAUSEA, VOMITING AND FEELING TIRED. DIAGNOSED DIABETIC KETOACIDOSIS. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283892 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization