BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3503730 · Received December 6, 2013

    Report

    Report Number
    2531779-2013-23358
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Report Date
    November 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2013 WITH THE FOLLOWING FINDINGS: CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS WHEN THE KEYPAD WAS REMOVED. THE KEYPAD WAS PEELING AT THE OK BUTTON. THE BUTTONS ON THE KEYPAD WERE RESPONDING PROPERLY. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION FOUND UNDER ALL OF THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED 11/25/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635306 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR