BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3844986 · Received June 3, 2014

    Report

    Report Number
    2531779-2014-15591
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. USER ERROR SHOULD BE CONSIDERED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) IN THE 400 MG/DL RANGE WITH SYMPTOMS OF NAUSEA AND AN UNSPECIFIED LEVEL OF KETONES. THE PATIENT STATED THERE WERE AIR BUBBLES IN THE CARTRIDGE. DURING TROUBLESHOOTING, CUSTOMER SUPPORT DETERMINED THAT THE PATIENT WAS NOT FILLING THE CARTRIDGE PROPERLY IN ACCORDANCE WITH THE IFU: THERE IS NO INDICATION OF PRODUCT MALFUNCTION. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324003 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening