BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3042478 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03838
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. THE CARTRIDGE WAS NOT REQUESTED FOR RETURN SINCE THERE WAS NO PRODUCT DEFECT IDENTIFIED. 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 ALLEGING THAT ON (B)(6) 2013 THE PATIENT WAS TAKEN TO THE E.R. FOR ELEVATED BLOOD GLUCOSE (BG) OVER 500MG/DL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS REPORTEDLY TREATED WITH IV FLUIDS AND INSULIN. THE PATIENT HAD REPORTEDLY ATTEMPTED TO CORRECT FOR ELEVATED BG PRIOR TO ER ADMISSION WITH THE PUMP AND INJECTIONS ON HIS OWN. THE PATIENT REPORTEDLY HAD THE STOMACH FLU AT THE TIME OF THE REPORTED INCIDENT, BUT IT WAS UNCLEAR IF THAT WAS THE SOLE CAUSE OF THE REPORTED INCIDENT OR NOT. DURING TROUBLESHOOTING, THE REPORTER NOTED AIR BUBBLES IN THE CARTRIDGE AND THE TUBING. A REVIEW OF CARTRIDGE PREPARATION FOUND INCORRECT CARTRIDGE FILL TECHNIQUE, RESULTING IN AIR BUBBLE FORMATION. THERE WAS NO DEFECT FOUND WITH THE CARTRIDGE, AND THE REPORTER WAS ADVISED ON APPROPRIATE TECHNIQUE TO AVOID AIR BUBBLES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WITH A POSSIBLE CONTRIBUTING FACTOR OF AIR BUBBLES IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145904 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention