BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800684 · Received October 22, 2012

    Report

    Report Number
    2032227-2012-07507
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER DOES NOT REMEMBER THE DETAILS OF THE EVENT. THE CALLER STATED THAT HE WAS IN THE HOSPITAL FOR FIVE DAYS WHILE HIS BLOOD GLUCOSE WAS TREATED AND BACK TO NORMAL, THEN HE WAS RELEASED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization