BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3914446 · Received July 3, 2014

    Report

    Report Number
    2032227-2014-03437
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 IN INTENSIVE CARE UNIT DUE TO URINARY TRACK INFECTION, HIGH BLOOD GLUCOSE AND KETOACIDOSIS. CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS 19.13 MMOL/L AT THE TIME OF ADMISSION. CALLER STATED THAT THE CUSTOMER WAS VOMITING AND THE PULSE WAS 150. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389324 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization