BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2101858 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03673
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER TO THE FDA WAS A PHARMACIST, UNKNOWN NAME, UNKNOWN ADDRESS, UNKNOWN PHONE NUMBER. CATALOG #100-124-02. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO PRODUCT WAS 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, PLUNGER, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REPORTED THROUGH THE MEDWATCH PROGRAM. (B)(4). THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. ACCORDING TO THE REPORT, A PHARMACIST REPORTED THAT A PATIENT'S MOTHER ALLEGED THAT AIR BUBBLES DEVELOPED IN THE CARTRIDGE DUE TO FAULTY CARTRIDGE O-RINGS. IT WAS REPORTED THAT THE PATIENT USED APPROXIMATELY SEVEN CARTRIDGES WITH THE SAME ALLEGED DEFECT. THE REPORT SAID THAT THE PATIENT THEN DISCONNECTED FROM THE PUMP AND USED INJECTIONS. THE COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION THAT A CARTRIDGE DEFECT MAY HAVE CAUSED AIR BUBBLES IN THE CARTRIDGE. IF THIS DEFECT EXISTS, THERE IS THE POTENTIAL FOR HYPERGLYCEMIA TO OCCUR BECAUSE AIR BUBBLES CAN MIGRATE FROM THE CARTRIDGE TO THE INFUSION SET TUBING AND BE DELIVERED IN PLACE OF INSULIN.

    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 B201500

    Patients

    Seq Age Sex Outcome Treatment
    1