BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3864556 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-02971
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    CUSTOMER REPORTED HE WAS HAVING ISSUES WITH THE INFUSION SET. THE NEEDLES WOULD HURT THE CUSTOMER BECAUSE THE CANNULA WOULD BEND. HE STATES THAT HE WAS NOT RECEIVING INSULIN AND THERE IS A LEAKAGE. CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING IS 410 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341433 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL A000114715

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization