BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2172484 · Received June 17, 2011

    Report

    Report Number
    2032227-2011-01450
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    THE CUSTOMER STATED THAT INSULIN LEAKED PAST THE O-RINGS. THE CUSTOMER COULD NOT REMEMBER IF THE LEAKS OCCURRED DURING FILLING OR DURING NORMAL USE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A WE1608244

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR