BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2081242 · Received April 26, 2011

    Report

    Report Number
    2032227-2011-01025
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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'S MOTHER CALLED FOR ASSISTANCE WITH A SOFTWARE PROGRAM. HOWEVER, WHILE ON THE CALL, THE CUSTOMER BEGAN TO EXPERIENCE HYPERGLYCEMIA, AND THE CUSTOMER'S MOTHER ENDED THE CALL BECAUSE SHE WAS GOING TO TAKE THE CUSTOMER TO THE EMERGENCY ROOM. THE CUSTOMER'S MOTHER WAS ASKED TO CALL BACK TO PERFORM TROUBLESHOOTING ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization