BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2123355 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01414
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVELS, THE CUSTOMER'S MOTHER NOTICED THAT INSULIN WAS LEAKING FROM THE TUBING AND RESERVOIR CONNECTION. ADVISED THE MOTHER THAT THE RESERVOIR WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC MINIMED MMT-332A GJ0407561

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR