BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 2251627 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-82501
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT SHE NOTICED THE INSULIN WAS LEAKING FROM THE RESERVOIR INTO THE RESERVOIR COMPARTMENT WHEN SHE WAS CHANGING THE INFUSION SET AND RESERVOIR. THE CUSTOMER STATED THAT SHE RAN A BOLUS AND ONLY SMALL AMOUNT OF INSULIN WAS COMING OUT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR