BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2043343 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01569
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 13, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. IT WAS NOTED THAT ALL KEYPAD BUTTON SYMBOLS WERE WORN. THE DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. ALL KEYPAD BUTTONS WERE OBSERVED TO SPRING BACK AS EXPECTED WHEN PRESSED. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAS BEEN SLOW TO RESPOND AND REQUIRES EXCESSIVE FORCE TO OBTAIN A RESPONSE FOR THE PAST WEEK. SHE NOTED THAT ALL OTHER KEYPAD BUTTONS ARE RESPONDING AS USUAL. THE FAMILY MEMBER REPORTED THAT THE KEYPAD BUTTONS SPRING BACK AS EXPECTED WHEN PRESSED. SHE DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO WATER OR CLEANING PRODUCTS; AND STATED THAT THE PATIENT WEARS THE PUMP IN VARIOUS PLACES WITH A CLIP OR CASE.

    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 13 YR