BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2573579 · Received May 14, 2012

    Report

    Report Number
    2531779-2012-04109
    Event Type
    Injury
    Date Received
    May 14, 2012
    Report Date
    April 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN CARTRIDGE SAMPLE FROM LOT # B201734 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. A FILL TEST WAS ALSO PERFORMED WITH NO AIR BUBBLES FORMING. A FORCE TEST WAS PERFORMED WITH NO DEFECTS FOUND. 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, ALLEGING THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (25.5 MMOL/L) WITH LARGE KETONES. THE REPORTER INDICATED THAT THEY NOTICED INSULIN LEAKING FROM THE LUER CONNECTION BETWEEN THE CARTRIDGE AND INFUSION SET. THE PATIENT'S BLOOD GLUCOSE LEVELS HAVE REPORTEDLY BEEN HIGH SINCE (B)(6) 2012. THE CARTRIDGE WAS INSPECTED AND NO DAMAGE WAS NOTED. THE LUER CONNECTION IS REPORTEDLY FINGER TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201734

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening