BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2070511 · Received March 29, 2011

    Report

    Report Number
    3004209178-2011-80835
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COULD SEE AND SMELL INSULIN INSIDE THE RESERVOIR COMPARTMENT OF THE INSULIN PUMP. THE CUSTOMER STATED THAT HE HAD BEEN RECEIVING NO DELIVERY ALARMS. THE CUSTOMER ALSO STATED THAT HE HAS HAD ELEVATED BLOOD GLUCOSE LEVELS AND WHILE BOLUSING, HE NOTICED THE INSULIN IN THE RESERVOIR COMPARTMENT. THE CUSTOMER FURTHER STATED THAT HE NOTICES AIR BUBBLES COMING UP FROM THE O-RINGS DURING FILLING. THE CUSTOMER THEN STATED THAT HE HAS HAD 4 OR 5 LEAKING RESERVOIRS. TROUBLESHOOTING WAS PERFORMED AND NO INSULIN WAS FOUND IN THE RESERVOIR COMPARTMENT AND NO INSULIN WAS LEAKING FORM 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 H7702097

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR