BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841786 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02716
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S SISTER-IN-LAW REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE LEVEL WAS 19 MG/DL. CUSTOMER'S SISTER-IN-LAW REPORTED THE CUSTOMER HAD BEEN HOSPITALIZED A WEEK PROIR TO EVENT DUE TO LOW BLOOD GLUCOSE LEVELS. CUSTOMER EXPERIENCING LOW BLOOD GLUCOSE FOR FOUR TO SIX WEEKS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319593 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization