BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2211320 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05871
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/27/2010 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. A LEAK TEST WAS PERFORMED AND A KEYPAD LEAK WAS OBSERVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS BECAME INTERMITTENTLY UNRESPONSIVE APPROXIMATELY TWO MONTHS PRIOR TO REPORTING THE ISSUE TO CUSTOMER SUPPORT. SHE STATED THAT SHE WORE THE PUMP IN A SWIMMING POOL ON ONE OCCASION. SHE DENIED DAMAGE TO THE KEYPAD, AND STATED THAT THE KEYPAD BUTTONS HAD "LIMITED CLICK AND SPRING-BACK."

    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 62 YR