BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942337 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03061
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THERE WAS NO DAMAGE TO KEYPAD OBSERVED. THE 'UP/DOWN/CONTRAST' BUTTONS WAS RESPONSIVE AND SPRING BACK WHEN PRESSED. THE 'OK' BUTTON WAS UNRESPONSIVE AND DOES NOT SPRINGS BACK WHEN PRESSED. THE "OK" BUTTON WAS NOTED TO BE INVERTED WHEN KEYPAD WAS REMOVED WHILE THE 'DOWN/CONTRAST/UP' BUTTON CONTACTS ARE NORMAL. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD MALFUNCTION. THERE WAS NO REPORT OF PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    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