BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2212279 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05896
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NO PRODUCT WAS RETURNED; A RETAIN SAMPLE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSES VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE OBSERVED TO THE LUER CONNECTION, O-RINGS, PLUNGER, OR CARTRIDGE BODY. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGE. A FORCE TEST WAS PERFORMED WITH NO FAILURES.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE CARTRIDGE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 WITH BLOOD GLUCOSE READING IN THE 400S MG/DL AND WAS TREATED FOR DKA AFTER THERE WAS A LEAKAGE ISSUE FOUND AT THE LEUR CONNECTION OF THE ANIMAS CARTRIDGE. THERE WERE NO ISSUES FOUND WITH THE ANIMAS PUMP, INFUSION SET, AND SITE. THE PRODUCT WAS NOT MISUSED. THE ANIMAS CARTRIDGE IS BEING RETURNED FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD MEDICAL INTERVENTION FOR DKA AFTER THE CARTRIDGE LEAKAGE ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201640

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R