BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2101574 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03659
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED, AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON EVALUATION RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10