BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2033335 · Received March 21, 2011

    Report

    Report Number
    2531779-2011-01814
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION REVEALED THAT THERE WAS CONTAMINATION UNDER THE DOWN BUTTON CONTACT. THE DOWN BUTTON INTERMITTENTLY ACTIVATED PUMP FUNCTIONS WHEN PRESSED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE DOWN ARROW BUTTON WAS STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1