BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061344 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04340
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/21/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE PUMP WAS TESTED WITH A NEW DISPLAY SCREEN AND THE DISPLAY SHOWED NORMALLY. UNRELATED TO THE COMPLAINT, THE KEYPAD COVER WAS TORN BETWEEN THE UP ARROW AND DOWN ARROW BUTTONS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/DISCOLORED SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162271 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR