BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4193609 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41423
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER RESERVOIR WAS LEAKING. THE CUSTOMER STATED SHE WAS FILLING HER RESERVOIR WHEN IT LEAKED ON HER HAND. THE CUSTOMER'S BLOOD GLUCOSE WAS 101 MG/DL. THE CUSTOMER WAS ADVISED THAT THE LEAK COULD BE FROM AN AIR BUBBLE IN THE RESERVOIR EXPANDING. THE CUSTOMER WAS ADVISED TO CHANGE HER RESERVOIR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672557 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR