BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1813400 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82581
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE CUSTOMER REPORTED THAT THE RESERVOIR WAS LEAKING PAST THE O-RINGS MORE THAN A WEEK AGO. THE CUSTOMER STATED THAT THE INSULIN LEAKED INTO THE RESERVOIR COMPARTMENT, AND THERE IS NO LONGER MOISTURE IN THE RESERVOIR. THE CUSTOMER STATED THAT THE RESERVOIR WAS DISPOSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7587851

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR