BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4244034 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50838
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD AIR BUBBLES IN THEIR RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. CUSTOMER ALSO STATED THEIR AIR BUBBLES WERE AN EIGHTH OR SIXTEENTH OF AN INCH WIDE. CUSTOMER ALSO REPORTED EXPERIENCING HIGH BLOOD GLUCOSE DUE TO THE AIR BUBBLES. THERE WAS ALSO NO LEAKS FOUND IN THE TUBING OR RESERVOIR ON THE CUSTOMER'S INSULIN PUMP. CUSTOMER WAS ADVISED THAT REWINDING WITH THE RESERVOIR IN PLACE WILL CREATE AIR BUBBLES. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725371 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG05YJ0

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR