BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2133077 · Received June 18, 2011

    Report

    Report Number
    2531779-2011-04265
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING TESTING, ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE. THE KEYPAD APPEARED WORN BUT WAS NOT TORN OR PEELING. WHEN THE RUBBER KEYPAD WAS REMOVED, ADHESIVE WAS FOUND UNDER THE KEY CONTACTS. A CRACK IN THE BATTERY COMPARTMENT WAS OBSERVED THAT WAS UNRELATED TO THE KEYPAD COMPLAINT AND UNDISCLOSED BY THE REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS DO NOT RESPOND WITH EVERY BUTTON PRESS. A DIABETES EDUCATOR REPORTED THAT THE PATIENT CONTINUES TO USE THE PUMP WITH INTERMITTENT RESPONSE. THERE WAS NO REPORT OF PROGRAMMING ERRORS DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR