BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1983298 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00676
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED. THE "UP/DOWN/OK" KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. THE "UP/DOWN" KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THE "UP/DOWN/OK/CONTRAST" KEY CONTACTS WERE ALSO OBSERVED TO BECOME INVERTED WHEN PRESSED AND WERE NOT ALWAYS SPRINGING BACK. EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE DOWN ARROW BUTTON REQUIRED SEVERAL PRESSES IN ORDER FOR THE PUMP TO RESPOND. SHE ALLEGED THAT THE BUTTON WAS STICKING AND THE PUMP WAS INTERMITTENTLY RESPONDING TO THE BUTTON PRESSES. THE PT DENIED THAT THE KEYPAD WAS DAMAGED. SHE ALSO DENIED THAT THE DEVICE WAS EXPOSED TO MOISTURE. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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