BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3063337 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04414
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 INVESTIGATION, THE DISPLAY LENS WAS NOTED TO BE SCRATCHED. THE DISPLAY ILLUMINATION WAS DIM, FADED AND PINK IN COLOR. A NEW TEST SCREEN 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)(6) 2013: THE DISPLAY LENS WAS NOTED TO BE SCRATCHED. THE ILLUMINATION OF THE DISPLAY WAS DIM, FADED AND PINK IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166218 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1