BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3200306 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02677
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 HIGH BLOOD GLUCOSE LEVELS AND KETONES. IT WAS REPORTED THAT THE CUSTOMER RECEIVED MOTOR ERROR AND NO DELIVERY ALARMS PRIOR TO THE HOSPITALIZATION. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET SEVERAL TIMES, BUT CONTINUED TO EXPERIENCE NO DELIVERY ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299671 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization