BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2103218 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03712
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, THE UP/OK/CONTRAST KEY CONTACTS WERE MISALIGNED AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD 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 CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR