BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3771772 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-83957
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH LOW BLOOD GLUCOSE. THE CUSTOMER'S SISTER STATED THAT THE INSULIN PUMP IS RESPONSIBLE FOR HIS ADMISSION. IT WAS STATED THAT THE CUSTOMER HAS BEEN ADJUSTING HIS OWN SETTINGS AND BOTTOMED OUT. HE RAN OFF AND EMBANKMENT INTO A BARN. THE CALLER ATTEMPTED TO UPLOAD THE INSULIN PUMP FOR HIS DOCTOR TO SEE THE SETTINGS AND TO ADJUST ANY SETTING THAT NEED ADJUSTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250176 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization