BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4143480 · Received October 6, 2014

    Report

    Report Number
    2531779-2014-28373
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/29/2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN HAD A DISCOLORED CONTRAST. THE KEYPAD WAS PEELING AND ALL OF THE BUTTONS HAD AN INTERMITTENT RESPONSE TO USER PRESSES. CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS WHEN THE KEYPAD WAS REMOVED. UNRELATED TO THE ISSUE, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DISCOLORED, THE KEYPAD WAS PEELING, THE BUTTONS HAD AN INTERMITTENT RESPONSE AND CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/29/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622920 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR