BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1923916 · Received December 13, 2010

    Report

    Report Number
    2531779-2010-02837
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE INTACT NO LIFTING OR PEELING. THE "OK" KEYPAD BUTTON IS INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING. THE "UP/DOWN/CONTRAST" KEYPAD BUTTONS REQUIRES EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. DURING A VISUAL INSPECTION, THE "UP/DOWN" KEY CONTACTS ARE MISALIGNED, THE "UP/DOWN/OK/CONTRAST" KEY CONTACTS BECOMES INVERTED WHEN PRESSED AND DO NOT ALWAYS SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE LAY-USER/PT ALLEGED THAT THE BUTTONS ON THE KEYPAD DO NOT RESPOND. THERE WAS PRODUCT MISUSE. THERE WAS NO REPORT THAT KEYPAD ON THE INSULIN PUMP WAS PEELED OR TORN. FURTHERMORE, 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

    Patients

    Seq Age Sex Outcome Treatment
    1