BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2063126 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81013
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A LEAKING RESERVOIR. THE CUSTOMER'S MOTHER STATED THAT THE LEAK WAS PAT BOTH O-RINGS AND THAT SHE NOTICED WHEN INSULIN LEAKED FROM THE BOTTOM DURING FILLING. THE CUSTOMER'S MOTHER ALSO STATED THAT SHE HAD TROUBLE WITH ANOTHER RESERVOIR WHEN SHE COULD NOT PUSH INSULIN BACK INTO THE VIAL WITH THE PLUNGER. 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 H7787931

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR