BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2111715 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03875
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/26/2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE OK AND CONTRAST KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE; THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS RESPONDED APPROPRIATELY TO USER INPUTS DURING TESTING. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE OK AND CONTRAST BUTTON KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST MONTH. SHE STATED THAT SHE WEARS THE PUMP IN HER POCKET, AND DOES NOT EXPOSE THE PUMP TO CLEANING PRODUCTS.

    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 63 YR