BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4132017 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30889
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN O RING COME OUT OF THE RESERVOIR AS WELL AS THE INSULIN. CUSTOMER STATED THAT SHE TRIED TO PULL BACK ON THE WHITE PART OF THE MIO AND IT WOULD NOT PULL BACK. CUSTOMER STATED THAT IS WAS STUCK. CUSTOMER WAS ADVISED THAT REPLACEMENTS WILL BE SENT OUT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610364 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A HG04LNB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR