BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2061364 · Received March 17, 2011

    Report

    Report Number
    2032227-2011-00681
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 5, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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

    THE CUSTOMER REPORTED INSULIN LEAKING FROM THE RESERVOIR INTO THE RESERVOIR COMPARTMENT. THE CUSTOMER NO LONGER HAS THE RESERVOIRS IN QUESTION. NOTHING COULD BE RETURNED FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR