BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN PUMP

    MDR report key: 1914016 · Received November 19, 2010

    Report

    Report Number
    2032227-2010-83224
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    January 8, 2010
    Report Date
    November 2, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 BY THE CUSTOMER'S ATTORNEY THAT THE INSULIN PUMP MALFUNCTIONED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR