BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2133794 · Received June 20, 2011

    Report

    Report Number
    2531779-2011-04276
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE 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. UNRELATED TO THE KEYPAD COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DOWN ARROW AND OK KEYPAD BUTTONS BECAME INTERMITTENTLY UNRESPONSIVE A FEW WEEKS AGO. HE STATED THAT THE BUTTONS SEEM TO GET STUCK, AND DO NOT HAVE APPROPRIATE SPRING BACK. HE NOTED THAT THE OK BUTTON IS WORN; STATED THAT HE WEARS THE PUMP IN HIS POCKET; AND DENIED EXPOSING 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 43 YR