BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2082049 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-81214
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    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 CUSTOMER HAD LEAKY RESERVOIRS. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER HAS CHANGED HER INFUSION SET FOUR TIMES IN THE LAST COUPLE OF DAYS TO TRY TO BRING HER HIGH BLOOD GLUCOSE LEVELS DOWN. THE CUSTOMER STATED THAT SHE HAD REC'D MANY NO DELIVERY ALARMS AND HAD CHANGED INFUSION SETS EVERY SINGLE TIME. THE CUSTOMER THEN STATED THAT THE RESERVOIRS HAVE BEEN LEAKING INTO THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR