BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4542611 · Received February 24, 2015

    Report

    Report Number
    2032227-2015-07864
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 13, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    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'S MOTHER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMR'S BLOOD GLUCOSE LEVEL WAS 50 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD. THE CUSTOMER WAS ADMITTED TO AVERA MEDICAL GROUP. THE CUSTOMER'S MOTHER DID NOT HAVE TIME TO COMPLETE THE TROUBLESHOOTING WILL CALL BACK AT LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130404 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization