BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3071526 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04801
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 26, 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: (B)(4) 2013 - DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE DISPLAY LENS WAS NOTED TO BE SCRATCHED. ON INVESTIGATION, THE TEXT THAT APPEARED ON THE DISPLAY WAS DIM, FADED, DISCOLORED AND DIFFICULT TO READ. A TEST DISPLAY WAS ATTACHED 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)(6) 2013: THE DISPLAY LENS WAS NOTED TO BE SCRATCHED AND THE TEXT IN THE DISPLAY SCREEN IS DIM, FADED AND DISCOLORED MAKING IT DIFFICULT TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172178 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1