BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3112623 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93471
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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 RESERVOIR LEAKED INSULIN. CUSTOMER'S BLOOD GLUCOSE READING IS 9.3 MMOL/L. CUSTOMER WAS REWINDING THE INSULIN PUMP TRYING TO REMOVE AIR BUBBLES WHEN THE LEAK OCCURRED. RESERVOIR LEAKED INSIDE THE RESERVOIR COMPARTMENT. LEAK IS PAST THE SECOND O-RING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213362 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1