BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3223025 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02887
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 7, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. PLEASE SEE ALSO MFR. REPORT NUMBER 2032227-2013-02886.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS GREATER THAN 500 MG/DL. THE CUSTOMER DID NOT KNOW WHY HIS BLOOD GLUCOSE LEVELS WERE HIGH, BUT STATED THAT HE WAS ALSO BEING TREATED FOR BRAIN CANCER. THE CUSTOMER ALSO STATED THAT THE HOSPITAL STAFF REMOVED AND DISCARDED THE TRANSMITTER AT THE TIME OF THE HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322794 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization