BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3900638 · Received June 27, 2014

    Report

    Report Number
    2531779-2014-18588
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/24/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS FOUND TO POWER ON WITH A FADED AND DISCOLORED DISPLAY SCREEN. UNRELATED TO THE DISPLAY ISSUE, THE PUMP KEYPAD WAS FOUND TO BE TORN AT THE OK BUTTON; THE KEYPAD WAS TESTED AND CONFIRMED THAT THE BUTTONS WERE RESPONDING APPROPRIATELY. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THE DISPLAY SCREEN WAS FADED AND DISCOLORED. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED 06/24/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377392 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR