BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3881277 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17455
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/13/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTED TO THE VERIFY SCREEN WITH A DIM AND DISCOLORED CONTRAST. THE BOLUS BUTTON WAS TORN, BUT THE BUTTON RESPONDED PROPERLY. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/13/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357277 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR