BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1032820 · Received April 21, 2008

    Report

    Report Number
    2032227-2008-00681
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    February 4, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT INSULIN LEAKED FROM THE RESERVOIR DUE TO A CRACK AT THE TUBING AND RESERVOIR CONNECTION. IT WAS STATED THAT THE LEAK WAS FOUND ON THE THIRD DAY OF USE. 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 UNK103A

    Patients

    Seq Age Sex Outcome Treatment
    1