BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192623 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09086
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS MISSING AND THE FUNCTIONALITY OF THE BOLUS BUTTON WAS NOT ABLE TO BE COMPLETED. A DAMAGED BUTTON COVER WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS A DAMAGED BUTTON SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. THERE WAS ALSO CONTAMINATION FOUND UNDER THE BUTTON KEY CONTACTS. ALL KEYPAD BUTTONS WERE FOUND TO BE RESPONSIVE TO USER INPUT.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS MISSING AND THE FUNCTIONALITY OF THE BOLUS BUTTON WAS NOT ABLE TO BE COMPLETED. THERE WAS ALSO CONTAMINATION FOUND UNDER THE BUTTON KEY CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294071 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR