BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2510248 · Received March 29, 2012

    Report

    Report Number
    2531779-2012-02608
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE CARTRIDGES HAVE 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

    (B)(4): THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN SAMPLE CARTRIDGE FROM LOT # B201710 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 AND A FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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 DISTRIBUTOR CONTACTED ANIMAS ON MARCH 2 AND REPORTED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE AND TUBING. THERE WERE NO LEAKS IDENTIFIED IN THE CARTRIDGE, AT THE TUBING, OR AT THE SKIN SITE. THE LUER LOCK WAS SECURE AND THE PATIENT WAS FILLING THE CARTRIDGE WITH ROOM TEMPERATURE INSULIN. THE PATIENT WAS ALSO REPORTEDLY PRESSURIZING THE VIAL OF INSULIN SLOWLY AND ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE WERE AIR BUBBLES REPORTEDLY FORMED IN THE CARTRIDGE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1