BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140662 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04482
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE DOWN AND OK BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PUMP WAS OPERATING WITHIN SPECIFICATION AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DOWN AND OK BUTTONS ARE NOT RESPONDING CORRECTLY TO BUTTON PRESSES. THE PATIENT REPORTED THAT IT FEELS LIKE THE BUTTONS ARE STICKING AT TIMES. THE PATIENT STATED THAT THE KEYPAD IS INTACT BUT FEELS LOOSE. THE PATIENT REPORTEDLY WORE THE PUMP IN A CASE ON HER BELT AND DID NOT CLEAN THE PUMP.

    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 29 YR