BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2943414 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-90689
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    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

    THE FATHER CALLED REQUESTING ASSISTANCE IN CHANGING THE PATTERN BASAL BACK TOT HE STANDARD BASAL. THE CALLER MENTIONED THAT THE CUSTOMER RECENTLY HAS BEEN IN THE HOSPITAL. THE FATHER STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE, BUT HE IS CONFIDENT THAT THE INSULIN PUMP IS FUNCTIONING AND TROUBLESHOOTING WAS DECLINED. ATTEMPTED TO CALL BACK TO GET MORE INFORMATION ON THE CUSTOMER'S HOSPITALIZATION. THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 400MG/DL. THE MOTHER STATED THAT THE CUSTOMER WAS VOMITING, AND HE HAD A BAD FLU AND SORE THROAT THE DAY BEFORE HIS ADMISSION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41102 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization