BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-103 24PK 3CC 13L

    MDR report key: 1172687 · Received September 19, 2008

    Report

    Report Number
    2032227-2008-01630
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT FOUR CUSTOMERS RETURNED RESERVOIRS THAT HAD LEAKED. THE DISTRIBUTOR STATED THAT THEY WILL CONTACT THE CUSTOMERS, AND ASK THAT THEY CALL TO REPORT THE INCIDENTS, AND HAVE THE RESERVOIRS RETURNED TO THE MANUFACTURER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-103 24PK 3CC 13L RESERVOIR FMF MEDTRONIC MINIMED MMT-103

    Patients

    Seq Age Sex Outcome Treatment
    1