BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3070460 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04735
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 25, 2013
    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

    (B)(6). SUBMITTED: 04/22/2013, DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON 03/25/2013 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE DISPLAY WAS NOTED TO BE FADED, DISCOLORED AND DIFFICULT TO READ. A TEST DISPLAY WAS CONNECTED TO THE PUMP AND ILLUMINATED PROPERLY.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: THE DISPLAY SCREEN WAS DIM, DISCOLORED AND DIFFICULT TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173085 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1