BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2123362 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81738
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD A LEAKY RESERVOIR. THE CUSTOMER STATED THAT SHE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS ATTEMPTED. UPON REMOVING THE RESERVOIR FROM THE RESERVOIR COMPARTMENT OF THE INSULIN PUMP, THE CUSTOMER FOUND THE RESERVOIR WET AND DID NOT KNOW WHERE THE INSULIN WAS COMING FROM. THE CUSTOMER FURTHER STATED THAT THE RESERVOIR COMPARTMENT DID NOT HAVE INSULIN INSIDE. 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 11 YR