BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942395 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-03077
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE KEYPAD APPEARED SWOLLEN, THE UP/DOWN/OK/CONTRAST BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUTS AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UP, DOWN ARROW AND OK BUTTONS HAD TO BE PRESSED MULTIPLE TIMES IN ORDER TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY INTACT AND THE PUMP HAS NOT BEEN EXPOSED TO MOISTURE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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