BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1893636 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-01993
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE 'UP' AND 'OK' BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. THE 'UP AND 'OK' BUTTON CONTACTS WERE FOUND TO BE MISALIGNED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE BUTTONS REQUIRE MULTIPLE PRESSES TO ELICIT A RESPONSE FROM THE PUMP. THE PT REPORTS NOT EXPOSING THE PUMP TO WATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR