BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2083265 · Received April 13, 2011

    Report

    Report Number
    3004209178-2011-81032
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 HAD A RESERVOIR THAT LEAKED PAST BOTH O-RINGS. THE CUSTOMER STATED THAT SHE SAW INSULIN TRICKLE ALL THE WAY DOWN PAST BOTH O-RINGS BUT NOT IN BETWEEN AND THAT THE LEAK WAS NOT AT THE TRANSFER GUARD. 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 H7373339

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR