BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2564469 · Received May 8, 2012

    Report

    Report Number
    2531779-2012-03882
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Report Date
    April 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/27/2012-DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN CARTRIDGE SAMPLE FROM LOT # B201780 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. 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

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THE PATIENT DISCOVERED INSULIN IN THE PUMP CARTRIDGE COMPARTMENT AND THAT THE CARTRIDGE WAS LEAKING. NO VISIBLE CRACKS OR DAMAGE WERE SEEN TO THE CARTRIDGE. THERE WAS NO ADVERSE EVENT 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 B201780

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR