BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2773827 · Received October 5, 2012

    Report

    Report Number
    2531779-2012-11903
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA 501K # SHOULD READ K042873.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION COMPLETED (B)(4) 2012: INVESTIGATION FOUND THE KEYPAD FULLY INTACT AND ALL KEYS RESPONSIVE. THE KEYPAD WAS REMOVED TO INVESTIGATE AND EVIDENCE OF KEYPAD CONTAMINATION WAS LOCATED, UNDER "CONTRAST" AND "DOWN" CONTACT BUTTONS. 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.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED EVIDENCE OF KEYPAD CONTAMINATION LOCATED UNDER "CONTRAST" AND "DOWN" CONTACT BUTTON THAT HAD NOT BEEN REPORTED BY THE USER. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.

    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 51 YR