BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3124006 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06863
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 REPORTER CONTACTED ANIMAS STATING ON (B)(6) 2013, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 565MG/DL AND TESTED POSITIVE FOR KETONES. IT WAS NOTED AFTER THE SITE/SET WAS REPLACED AND THE PATIENT WAS TREATED WITH A BOLUS FROM THE PUMP AND GIVEN A CORRECTION INJECTION, THE PATIENT¿S BG ISSUE DID NOT RESOLVE. THE PATIENT REPORTEDLY WAS HOSPITALIZED ON (B)(6) 2013; THE PATIENT WAS TREATED VIA INTRAVENOUS INSULIN AND THE PATIENT¿S BG REPORTEDLY WENT DOWN TO 110MGDL. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP; THERE WAS NO INDICATION OF A PUMP MALFUNCTION AND THE PATIENT CONTINUED TO USE THE PUMP. THERE WAS REPORTEDLY AIR BUBBLES NOTED IN THE TUBING AND IN THE CARTRIDGE. IT WAS NOTED DURING A REVIEW OF THE REPORTER¿S TECHNIQUE; THE REPORTER HAD PUSHED ALL OF THE INSULIN BACK INTO THE INSULIN VIAL AND THEN IMMEDIATELY REFILLED THE CARTRIDGE WHICH MAY HAVE CAUSED AIR BUBBLES TO FORM INTO THE CARTRIDGE AND IN THE TUBING. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED BG EXCURSION DUE AN INCORRECT TECHNIQUE USED TO REMOVE AIR BUBBLES FROM THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225785 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| L| R