BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2871832 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-91183
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 24, 2012
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 21MG/DL. THE FATHER STATED THAT THE CUSTOMER WENT TO SLEEP, AND HER DAUGHTER WILL CALL BACK WHEN SHE IS AVAILABLE TO CONTINUE TROUBLESHOOTING. DAYS LATER, THE CUSTOMER CALLED BACK AND STATED THAT SHE IS NOT SURE IF SHE TOOK TOO MUCH INSULIN VIA BOLUS BEFORE SHE FELT ASLEEP ON THE COUCH, BUT SHE IS NOT HAVING ISSUES ANYMORE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization