BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3120995 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02009
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 REPORTED THAT SHE WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE OF 26 MG/DL. THE CUSTOMER STATED THAT SHE HAD AN INFECTION, BUT NOW THAT THE INFECTION IS GONE, HER DOCTOR HAS TAKEN HER OFF OF INSULIN PUMP THERAPY. THE CUSTOMER STATED THAT SHE WAS TOLD SHE DOESN'T NEED AS MUCH INSULIN ANYMORE, AND WILL BE OFF THE INSULIN PUMP FOR AT LEAST A MONTH. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT, AND STATED THAT SHE WILL CALL BACK ONCE SHE'S BACK ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222638 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization