BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 3234114 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11313
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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, THE PATIENT CONTACTED ANIMAS TO ASK QUESTIONS ABOUT AN ADVANCED FEATURE OF THE PUMP. THE PATIENT MENTIONED THAT BG WAS AS HIGH AS 500MG/DL ON OCCASION DURING THE PAST 2-3 MONTHS AND THE CAUSE WAS NOT IDENTIFIED. THE ONLY SYMPTOM THE PATIENT REPORTED WAS HEADACHES. THE PATIENT WAS SAID TO BE USING U500 INSULIN IN THE PUMP. DURING TROUBLE SHOOTING, THE PATIENT DISCOVERED AIR BUBBLES IN THE CARTRIDGE. CUSTOMER TECHNICAL SUPPORT FOUND THE CAUSE OF THE AIR BUBBLES TO BE USE ERROR. THE PATIENT WAS INSTRUCTED ON TECHNIQUES TO AVOID AIR BUBBLE PRODUCTION WHEN FILLING THE CARTRIDGE AND WAS REMINDED TO INSPECT THE TUBING PERIODICALLY TO REMOVE AIR BUBBLES IF NEEDED. NO PRODUCT ISSUE WAS DISCOVERED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO AIR BUBBLES IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333978 OTHER INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening