BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1982576 · Received January 12, 2011

    Report

    Report Number
    2531779-2011-00194
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Report Date
    December 13, 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 EVALUATION AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE OK/CONTRAST KEY CONTACTS WERE INTERMITTENTLY RESPONDING TO USER INPUTS, THE UP/DOWN KEYS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, THE UP/DOWN KEY CONTACTS WERE MISALIGNED, THE UP/DOWN/OK/CONTRAST KEY CONTACTS BECAME INVERTED DURING TESTING, 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 CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1