BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2156413 · Received July 11, 2011

    Report

    Report Number
    2531779-2011-04810
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #: B201582. CATALOG #:100-124-01. (B)(6). CORRECTION NUMBER: 2531779-02/25/11-001-R. 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 # 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

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) BETWEEN 220 MG/DL AND 280 MG/DL IN (B)(6) 2011 WHILE USING CARTRIDGES FROM LOT # B201582. SHE STATED THAT THERE WERE AIR BUBBLES NOTED COMING FROM THE BOTTOM O-RING OF THE CARTRIDGE, AND THE PATIENT STATED THAT HE NOTICED THE SMELL OF INSULIN. THE REPORTED BG EXCURSIONS DO NOT MEET THE DEFINITION OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGED CARTRIDGE MALFUNCTION.

    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 11 YR