BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN NFUSION PUMP

    MDR report key: 2041934 · Received March 29, 2011

    Report

    Report Number
    2032227-2011-00782
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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 WITH A LOW BLOOD GLUCOSE READING OF 22 MG/DL. ON THE MORNING OF THE EVENT, THE CUSTOMER GOT A NO DELIVERY ALARM, AND DELIVERED A DOUBLE BOLUS, WHICH WAS 50 UNITS. LATER, THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS, AND LEFT SCHOOL WITH A HEADACHE. THE INFUSION SET BEING USED AT THE TIME WAS AN MMT-399, LOT #9201968. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN NFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization