BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3190282 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09009
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/20/2013, DEVICE EVALUATION: THE RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED IN THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT WAS TAKEN TO THE ER FOR BLOOD GLUCOSE (BG) OVER 700MG/DL WITH SEVERE NAUSEA, VOMITING, AND HEADACHE DUE TO A LEAKING CARTRIDGE. THE INFUSION SET AND CARTRIDGE WERE REPORTEDLY CHANGED THE EVENING OF (B)(6) 2013, AND THE PATIENT AWOKE WITH ELEVATED BG ON (B)(6) 2013 AND WAS ADMITTED TO THE ICU. THE PATIENT WAS REPORTEDLY DIAGNOSED WITH DIABETIC KETOACIDOSIS AND WAS GIVEN IV INSULIN AND IV FLUIDS. THE LEAKING CARTRIDGE WAS REPORTEDLY DISCOVERED WHEN THE PATIENT ATTEMPTED TO RESUME THE PUMP ON (B)(6) 2013. THE PATIENT WAS OFF THE PUMP AT THE TIME OF THE CALL TO ANIMAS AND WAS TO BE DISCHARGED ON INSULIN INJECTIONS. THE PATIENT REPORTED THAT THE INSULIN WAS LEAKING OUT NEAR THE O-RING; THERE WAS REPORTEDLY NO VISIBLE DAMAGE TO THE CARTRIDGE. THE REPORTER DENIED ANY ISSUES WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION DUE TO A LEAKING CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289589 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B201974

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| L| R