BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2494309 · Received March 16, 2012

    Report

    Report Number
    2531779-2012-02158
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Report Date
    February 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN SAMPLE FROM LOT # B201754 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 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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. NO CONCLUSIONS CAN BE MADE AT THIS TIME. LOT#: NOT PROVIDED

    Description of Event or Problem · 1

    ON (B)(6), 2012 THE PATIENT CONTACTED ANIMAS TO REPORT THE INSULIN CARTRIDGE HAD AIR BUBBLES IN IT. TROUBLESHOOTING REVEALED THE PATIENT SOMETIMES USED REFRIGERATED INSULIN WHICH CAN CONTRIBUTE TO AIR BUBBLES. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    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 37 YR