BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8CC

    MDR report key: 2063093 · Received March 16, 2011

    Report

    Report Number
    3004209178-2011-80676
    Event Type
    Malfunction
    Date Received
    March 16, 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
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 BY THE CUSTOMER THAT THE RESERVOIR IS LEAKING. THE CUSTOMER STATED THAT HE WAS RECEIVING AIR BUBBLES AND THAT HE WORKS OUTSIDE IN A COLD ENVIRONMENT. THE CUSTOMER ALSO STATED THAT HE SMELLED INSULIN IN THE RESERVOIR CHAMBER AND THAT HE DID NOT PULL OUT THE O-RINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326AT H7774297

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR