BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2051852 · Received March 15, 2011

    Report

    Report Number
    3004209178-2011-80657
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S MOTHER THAT INSULIN WAS COMING OUT FROM THE RESERVOIR COMPARTMENT OF THE CUSTOMER'S INSULIN PUMP. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS UP TO 575 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT PASS THE FIXED PRIME. THE CUSTOMER'S MOTHER STATED THAT SHE NOTICED INSULIN COMING OUT FROM THE RESERVOIR COMPARTMENT. THE CUSTOMER'S MOTHER ALSO STATED THAT THE LEAKING WAS FROM SOMEWHERE CLOSE TO THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR