BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3514222 · Received December 11, 2013

    Report

    Report Number
    2531779-2013-23777
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Report Date
    December 2, 2013
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE DURING TESTING AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER THE BUTTON. EVALUATION ALSO REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. 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 A CRACKED BATTERY COMPARTMENT, A DISPLAY FAILURE AND CONTAMINATION UNDER THE BOLUS BUTTON WITH A RESPONSE ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/02/2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649349 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1