BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3122300 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06801
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WHILE ON A CALL TO RESOLVE ANOTHER ISSUE, THE REPORTER STATED THAT SHED NOTICED A FEW AIR BUBBLES IN THE CARTRIDGE PATIENT IS PUSHING AIR INTO THE CARTRIDGE, AND NOT EXPELLING IT INTO THE AIR.. CUSTOMER TECHNICAL SUPPORT TALKED PATIENT THROUGH FILLING CARTRIDGE; EXPLAINED PROPER TECHNIQUE TO AVOID AIR BUBBLES, ESPECIALLY NOT OVER PRESSURIZING VIAL AND USING ROOM TEMPERATURE INSULIN. CTS ADVISED PATIENT IF AIR IS PRESENT IN CARTRIDGE TO REMOVE NEEDLE AND PUSH AIR OUT OF CARTRIDGE INTO AIR, NOT TO PUSH AIR BACK INTO VIAL. THERE IS NO ALLEGATION OF AN ADVERSE EVENT OR PRODUCT MALFUNCTION. THIS COMPLAINT IS BEING REPORTED DUE TO USER ERROR OF INCORRECTLY FILLING THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223903 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR