BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2472862 · Received February 29, 2012

    Report

    Report Number
    2531779-2012-01646
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    October 31, 2011
    Report Date
    December 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 2/02/2012 WITH THE FOLLOWING FINDINGS: THE AUDIO BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE. UNRELATED TO THE EVENT THE DISPLAY WAS FOUND TO BE DIM.

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 2/02/2012 WITH THE FOLLOWING FINDINGS: THE AUDIO BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE. 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