BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4230067 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-37000
    Event Type
    Malfunction
    Date Received
    October 11, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 CONCLUSIONS 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

    IT WAS REPORTED THE CUSTOMER HAD AIR BUBBLES IN THE RESERVOIR. IT WAS FOUND THE CUSTOMER WAS HANDLING THE INSULIN CORRECTLY. THE CUSTOMER ALSO REPORTED THAT THE AIR BUBBLES USUALLY OCCUR 10 HOURS AFTER A NEW INFUSION SET IS FILLED. CUSTOMER'S BLOOD GLUCOSE WAS 351 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645460 RESERVOIR 3ML FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-322A

    Patients

    Seq Age Sex Outcome Treatment
    1