BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3183255 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-94935
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL AND BLURRY VISION. THE FATHER STATED THAT SHE WAS NOT CONNECTED TO THE INSULIN PUMP AT TIME OF HER ADMISSION. THE CALLER STATED THAT THE BATTERY IS MISSING, AND HE REQUESTED A BATTERY CAP. THE CUSTOMER WAS ATTEMPTING TO UPLOAD THE INSULIN PUMP TO THE CARELINK, BUT THE COMMUNICATION ENDED SINCE THE CUSTOMER WAS USING A CELL PHONE. ATTEMPTED TO CONTACT THE CALLER SEVERAL TIMES WITHOUT RESULTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284118 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization