BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2051900 · Received March 14, 2011

    Report

    Report Number
    2531779-2011-01548
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE OK KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE OK BUTTON SYMBOL IS WORN, AND THE BUTTON IS NOT SPRINGING BACK AS EXPECTED. HE STATED THAT IT REQUIRES SEVERAL BUTTON PRESSES FOR THE OK BUTTON TO RESPOND, AND THAT THE BUTTON FEELS HARD TO PRESS. THE PATIENT NOTED THAT ALL OTHER BUTTONS ARE RESPONDING AS EXPECTED. HE CONFIRMED THAT THERE IS NO STRUCTURAL DAMAGE TO THE RUBBER KEYPAD; STATED THAT HE DOES NOT EXPOSE THE PUMP TO WATER; AND STATED THAT HE WEARS THE PUMP WITH A CLIP.

    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 68 YR