BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3121017 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93652
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED BETWEEN THE O-RINGS AND INSULIN WAS FOUND IN THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221557 RESERVOIR 1.8ML RESERVOIR FRN MMT-326A H8500423

    Patients

    Seq Age Sex Outcome Treatment
    1