BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2040009 · Received March 25, 2011

    Report

    Report Number
    2531779-2011-01916
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL BUTTON KEY CONTACTS. UNRELATED TO THE KEYPAD COMPLAINT, INVESTIGATION REVEALED A DISCOLOURED DISPLAY SCREEN AND A CRACKED BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE BECOME INCREASINGLY UNRESPONSIVE OVER THE PAST SEVERAL DAYS. SHE NOTED THAT THE BUTTONS FEEL FLAT WHEN PRESSED. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO WATER; AND STATED THAT THE PATIENT CARRIES THE PUMP IN HER POCKET.

    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 20 YR