BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3890194 · Received June 24, 2014

    Report

    Report Number
    2531779-2014-18063
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    June 10, 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 06/10/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS FUNCTIONED NORMALLY. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE CONTRAST AND DOWN ARROW BUTTON KEY CONTACTS. THE AUDIO BOLUS BUTTON COVER WAS TORN, EXPOSING THE BOLUS BUTTON ¿SLUG¿. ADDITIONALLY, THE PUMP POWERED ON TO A DIM, DISCOLORED DISPLAY, AND THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. 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 CONTAMINATION UNDER THE BUTTON CONTACTS, A DIM/DISCOLORED DISPLAY SCREEN, AND A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368177 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1