BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3924509 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19477
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON TO A DIM DISCOLORED DISPLAY. A BATTERY COMPARTMENT CRACK WAS OBSERVED FROM THE THREAD AREA TO THE CASE SEAL. THE KEYPAD WAS TORN AT THE CONTRAST BUTTON AND WAS PEELING. THE CONTRAST KEY WAS NOT RESPONDING. THE UP AND DOWN KEYS WERE INTERMITTENTLY UNRESPONSIVE. THE CONTRAST BUTTON CONTACT WAS MISSING. CONTAMINATION WAS FOUND UNDERNEATH THE UP AND DOWN KEY CONTACTS. 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)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED UNRESPONSIVE KEYPAD BUTTONS WITH CONTAMINATION ON THE KEYPAD CONTACTS AND A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401717 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1