BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233439 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11264
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 19, 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: THE PUMP DISPLAY LENS WAS FOUND TO HAVE MULTIPLE SCRATCHES. THE PUMP POWERED ON AND BOOTED TO THE VERIFY SCREEN WITH A FADED AND DISCOLORED DISPLAY SCREEN. THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL. UNRELATED TO THE DISPLAY ISSUE, THE KEYPAD WAS FOUND TO BE TORN AT THE OK BUTTON; ALL OF THE KEYPAD BUTTONS WERE CONFIRMED TO BE RESPONSIVE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS AND WAS INVESTIGATED BY PRODUCT ANALYSIS ON 06/19/2013. INVESTIGATION FOUND THAT THE DISPLAY SCREEN WAS FADED AND DISCOLORED. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334282 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR