BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2042920 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02070
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVAL REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE, AND MULTIPLE PRESSES ARE REQUIRED TO OBTAIN A RESPONSE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE ALL BUTTON KEY CONTACTS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT THE KEYPAD BUTTONS ARE UNRESPONSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1