BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2429004 · Received January 26, 2012

    Report

    Report Number
    2531779-2012-00663
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Report Date
    December 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): THE CARTRIDGE WAS RETURNED TO ANIMAS FROM LOT# B201737 AND LOT # B201724. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION OR O-RINGS OF THE CARTRIDGE. A FILL TEST WAS ALSO PERFORMED AND NO AIR BUBBLES WERE OBSERVED INSIDE THE CARTRIDGE. 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

    IT WAS REPORTED THAT THE PATIENT NOTICED ISSUES WITH AIR BUBBLES IN THE CARTRIDGE, LUER LOCK AND TUBING. THE PATIENT REPORTED THAT THE AIR BUBBLES CAUSE APPROXIMATELY 1 INCH GAPS IN THE TUBING THAT AFFECT BLOOD GLUCOSE LEVELS. THE PATIENT'S BLOOD GLUCOSE LEVELS HAVE REPORTEDLY RISEN TO 300MG/DL. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION DUE TO THIS. THE PATIENT WILL REPORTEDLY PRIME OUT THE AIR BUBBLES OR CHANGE OUT THE TUBING AND CARTRIDGE WHEN THIS OCCURS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR