BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033416 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01870
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORP.
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201582 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 REPORTED THAT SHE HAS HAD REPEATING ISSUES OF AIR BUBBLES IN THE CARTRIDGE WHEN USING CART LOT B201582. THE REPORTER DENIED THAT THE PT HAS DEVELOPED ANY BG EXCURSION OR HAS HAD TO RECEIVE MEDICAL INTERVENTION FOR HYPERGLYCEMIA AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE PT'S MOTHER CLAIMED SHE DISCARDED THE AFFECTED SUPPLIES. THE REPORTER CONFIRMED SHE WAS FILLING THE CARTRIDGE PROPERLY, USING ROOM TEMPERATURE INSULIN AND DEBUBBLING CORRECTLY. NO LEAKING OF THE CARTRIDGE WAS NOTED. 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 CORP. IR 1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1