BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1935477 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02880
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 17, 2010
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    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 "UP/DOWN/OK" KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING. THE "CONTRAST" KEYPAD BUTTON REQUIRES EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. DURING A VISUAL INSPECTION, THE "DOWN/CONTRAST" KEY CONTACTS ARE MISALIGNED, THE "CONTRAST" KEY CONTACT IS INVERTED, AND THE "UP/DOWN/OK" KEY CONTACTS BECOME 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. THE KEYPAD DID NOT APPEAR TO BE 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 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1