BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2079728 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02337
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/2011/001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE [WAS/WAS NOT] RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED, THERE IS NOT FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT CLAIMED SHE NOTICED INSULIN LEAKING FROM 2 OF HER INSULIN CARTRIDGES (LOT B201583) WITHIN THE PAST 2 MONTHS. SHE INDICATED THAT THE INSULIN WAS LEAKING NEAR THE PLUNGER OF THE CARTRIDGE. THE PT DID NOT USE THE CARTRIDGES AND DISCARDED THEM. THE ANIMAS CUSTOMER SUPPORT REP CONFIRMED THE PROVIDED LOT NUMBER IS PART OF A RECALL. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. REPLACEMENT CARTRIDGES WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR1200/1250/2020/OTP B201583

    Patients

    Seq Age Sex Outcome Treatment
    1