BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2070789 · Received April 14, 2011

    Report

    Report Number
    2531779-2011-02600
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED, THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT'S MOTHER ALLEGED THAT 2-3 WEEKS PRIOR TO CONTACTING ANIMAS, THE PT NOTICED A CARTRIDGE WAS LEAKING FROM LUER LOCK END. IT WAS REPORTED THAT THE LEAK STOPPED AFTER THE PT TIGHTENED THE TUBING. THE PT DENIED HAVING A BLOOD GLUCOSE EXCURSION AS A RESULT OF LEAK. THE PT'S MOTHER MENTIONED THAT A DROP OF INSULIN WENT INTO HIS EYE WHILE EXAMINING THE CARTRIDGE. THE REPORTER CLAIMED THAT THE PT WASHED OUT HIS EYE AND NO MEDICAL ATTENTION WAS NECESSARY. IT WAS NOTED THAT THE CARTRIDGE WAS NOT SAVED FOR RETURN. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020/ OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1