BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2060762 · Received April 8, 2011

    Report

    Report Number
    3004209178-2011-80984
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 HAD THREE RESERVOIRS THAT LEAKED PAST BOTH O-RINGS. THE CUSTOMER STATED THAT THE LEAK WAS NOTICED WHEN THE CUSTOMER WAS FILLING THE RESERVOIR WITH INSULIN. THE CUSTOMER ALSO STATED THAT THE RESERVOIR HAD BEEN USED FOR TWO DAYS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7766383

    Patients

    Seq Age Sex Outcome Treatment
    1