BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2061360 · Received March 17, 2011

    Report

    Report Number
    3004209178-2011-80708
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE RESERVOIR WAS LEAKING INSULIN INTO THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE NOTICED HER RESERVOIR ICON DROP SUDDENLY AND DISCOVERED THE LEAK. THE CUSTOMER ALSO STATED THAT THE INSULIN WENT PAST BOTH O-RINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7754500

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR