BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3231459 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02938
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    May 19, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 500 MG/DL. CALLER STATED THAT THE CUSTOMER HAD HEADACHE, STOMACH PAIN AND WAS VOMITING PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332179 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization