BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2072546 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-81174
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LEAKY RESERVOIRS. THE CUSTOMER'S GRANDMOTHER STATED THAT THE CUSTOMER HAD AIR BUBBLES IN THE TUBING AND THE RESERVOIR. THE CUSTOMER'S GRANDMOTHER STATED THAT THE LEAK IS PAST BOTH O-RINGS, THAT THE BOTTOM OF THE RESERVOIR IS WET AND THAT THE INSIDE OF THE INSULIN PUMP IS DRY BUT SMELLS OF INSULIN. 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 H7765342

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR