BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-103A 10PK 3CC 13L STRL

    MDR report key: 1190556 · Received October 2, 2008

    Report

    Report Number
    2032227-2008-01695
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PROD 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-103A 10PK 3CC 13L STRL RESERVOIR FMF MEDTRONIC MINIMED MMT-103A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR