BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2170585 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05093
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED, A RETAINED SAMPLE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSED VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    LOT #: B201636, SERIAL #: N/A. THE CARTRIDGE 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED LEAKY CARTRIDGES FROM LOT # B201636. HE STATED THAT IT HAS BEEN OCCURRING FOR ABOUT A MONTH. THE PATIENT REPORTED THAT THE CARTRIDGES SEEM TO BE LEAKING FROM THE BOTTOM; HE HAS NOTED AIR BUBBLES IN THE CARTRIDGES AND THE TUBING. HE STATED THAT HE HAS TO RE-PRIME TO CLEAR THE AIR BUBBLES.

    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 52 YR