BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2083270 · Received April 13, 2011

    Report

    Report Number
    3004209178-2011-81049
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S RESERVOIR WAS LEAKING PAST BOTH O-RINGS. THE CUSTOMER STATED THAT INSULIN HAD LEAKED INTO THE RESERVOIR COMPARTMENT OF THE INSULIN PUMP DURING A NORMAL INFUSION SET CHANGE. THE CUSTOMER FURTHER STATED THAT THE RESERVOIR COMPARTMENT HAS DRIED OUT COMPLETELY. THE CUSTOMER THEN STATES THAT INSULIN LEAKED AT THE BASE OF THE RESERVOIR 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 H7759451

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR