BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2916879 · Received January 15, 2013

    Report

    Report Number
    2531779-2013-00695
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    December 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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 (B)(4) 2013 - DEVICE EVALUATION: A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER B201927 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FORCE TEST, A FILL TEST, AND A LEAK TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 INDICATING THAT THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL OF 500MG/DL WITH EXCESSIVE URINATION AND THIRST. THE PATIENT REPORTEDLY NOTICED THAT INSULIN WAS LEAKING IN THE CARTRIDGE COMPARTMENT. THE PATIENT WAS UNSURE IF THE LEAKING WAS FROM THE LUER CONNECTION OR THE CARTRIDGE PLUNGER. THIS REPORT IS BEING MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS RELATED TO A LEAKING CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21791 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201927

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening