BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2050364 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-80903
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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 A LEAKING RESERVOIR. THE CUSTOMER STATED THAT AFTER CHANGING RESERVOIRS, THE NEW RESERVOIR HAD ONLY 36.8 UNITS WHEN SHE HAD FILLED THE RESERVOIR WITH 100 UNITS. THE CUSTOMER THEN STATED THAT SHE SMELLED INSULIN IN THE RESERVOIR COMPARTMENT OF THE INSULIN PUMP AND HEARD SWISHING IN THE INSULIN PUMP WHEN IT WAS SHAKEN. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. 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 H7769687

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR