BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3965065 · Received July 29, 2014

    Report

    Report Number
    2531779-2014-21739
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    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: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. ON INVESTIGATION, A CRACK EXTENDING FROM THE THREADS TO THE BASE SEAL WAS FOUND IN THE BATTERY COMPARTMENT. THE PUMP POWERED UP TO A DIM AND DISCOLORED VERIFY SCREEN. UNRELATED TO THE CASING AND DISPLAY ISSUES, THE COVER OF THE BOLUS BUTTON WAS FOUND MISSING/DETACHED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED, AND THE DISPLAY WAS DIM/DISCOLORED, 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
    440867 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1