BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1214048 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-00881
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE CUSTOMER STATED THAT INSULIN LEAKED FROM THE RESERVOIR INTO THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7310079

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR