BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3171142 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02458
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 HYPOGLYCEMIA. IT WAS STATED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS THE DAY BEFORE, AND HAD TO CHANGE THE INFUSION SET. IT WAS STATED THAT THE CUSTOM DELIVERED A LARGE BOLUS THAT RESULTED IN LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ALSO ACCURATE. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271771 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization