BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192804 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95176
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 CALLED TO REPORT A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 64 MG/DL. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 53 MG/DL. CUSTOMER STATED THAT THE BLOOD GLUCOSE LEVEL WOULD DECREASE WITHOUT REASON. CUSTOMER EXPERIENCED VOMITING, UPSET STOMACH. PARAMEDICS WERE CALLED DUE TO GOING LOW. WHILE IN THE HOSPITAL THE ENDOCRINOLOGIST CHANGED THE BASAL SETTINGS, THERE WERE TOO HIGH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291959 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization