BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2062020 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-80717
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 THAT HER RESERVOIRS WERE LEAKING. THE CUSTOMER STATED THAT IT HAPPENED 4 TIMES IN THE LAST MONTH, WITH DIFFERENT SETS, AND LEAKED INTO THE INSULIN PUMP. THE CUSTOMER ALSO STATED THAT SHE SOMETIMES PULLS THE PLUNGER ALL THE WAY OUT OF THE RESERVOIR. EXPLAINED TO CUSTOMER THAT THE PLUNGER NEEDS TO STAY IN THE RESERVOIR. 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 49 YR