BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140884 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04485
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 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
    VT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/17/2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE UP ARROW AND CONTRAST KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. IT WAS OBSERVED THAT THE UP ARROW BUTTON AND CONTRAST BUTTON DO NOT CLICK OR SPRING BACK NORMALLY WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE NOTICED TWO DAYS AGO THAT THE UP ARROW KEYPAD BUTTON WAS FLAT AND INTERMITTENTLY UNRESPONSIVE. SHE DENIED EXPOSING THE PUMP TO CLEANING PRODUCTS, AND CONFIRMED THAT THERE WERE NO HOLES OR TEARS IN THE KEYPAD.

    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 38 YR