BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2911628 · Received April 7, 2008

    Report

    Report Number
    2531779-2008-00195
    Event Type
    Malfunction
    Date Received
    April 7, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DAMAGED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PUMP WAS RESETTING ITSELF WITHOUT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR