BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2031815 · Received March 21, 2011

    Report

    Report Number
    2531779-2011-01755
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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
    WA, 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. 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

    THE PATIENT REPORTED THAT THREE CARTRIDGES LEAKED INSULIN FROM AROUND THE BLACK O-RING AND OUT THROUGH THE PLUNGER END OF THE CARTRIDGE. HE STATED THAT HIS BLOOD GLUCOSE ELEVATED TO 240 MG/DL; HE DENIED SYMPTOMS OF HYPERGLYCEMIA OR THE PRESENCE OF KETONES. THE PATIENT REPORTED THAT HE PREPARES AND STORES THE CARTRIDGES AS INSTRUCTED AND HE DOES NOT REUSE CARTRIDGES. HE NOTED THAT THEY ARE NOT EXPIRED AND THEY DO NOT HAVE VISIBLE DAMAGE.

    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 42 YR