BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2221821 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06178
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 UP AND DOWN ARROW BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES AND REQUIRED INCREASED FORCE TO ENGAGE. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. 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. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE UP ARROW BUTTONS WERE REALLY HARD TO GET TO WORK; SHE WAS UNSURE ON HOW LONG THE PUMP HAD THIS ISSUE. THE PATIENT REPORTEDLY WORE THE PUMP IN A PUMP CASE IN A POCKET AND CLEANED THE PUMP WITH A DAMP PAPER TOWEL.

    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 13 YR