BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2142267 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04521
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. EVALUATION REVEALED THAT THE KEYPAD WAS TORN. A TORN KEYPAD 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 THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. ADDITIONALLY MOISTURE WAS OBSERVED UNDER THE DISPLAY. THE PUMP WAS UNABLE TO POWER ON. THE PUMP WAS OPENED AND MOISTURE WAS OBSERVED IN THE CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE RUBBER ON THE OK BUTTON STARTED PEELING ONE WEEK AGO. SHE ALSO REPORTED THAT SHE THINKS THE PUMP GOT WET AT SCHOOL TODAY AND NOW HAS NO POWER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR