BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2032310 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01868
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 11, 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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT #B201576 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 PATIENT'S FATHER CONTACTED ANIMAS ALLEGING THAT THE PATIENT'S BLOOD GLUCOSE (BG) HAS BEEN FLUCTUATING FOR THE PAST 3 MONTHS. THE REPORTER CLAIMED HE RECEIVED AN EMAIL FROM ANIMAS REGARDING A FIELD CORRECTION FOR LEAKING CARTRIDGES AND FEELS THAT THE PATIENT'S BG EXCURSION MAY HAVE BEEN AS A RESULT OF USING ONE OF THE AFFECTED LOTS. THE PATIENT'S FATHER STATED THAT ON (B)(6) 2011, THE PATIENT WAS TAKEN TO THE HOSPITAL FOR A HIGH BG. THE PATIENT'S FATHER CLAIMED THE PATIENT WAS TESTING IN 300-400 MG/DL, TESTED POSITIVE FOR KETONES AND HAD SYMPTOMS OF NAUSEA AND VOMITING. IT WAS REPORTED THAT THE PATIENT WAS KEPT ON THE PUMP WHILE AT THE HOSPITAL AND WAS TREATED WITH INJECTIONS AND DISCHARGED THE FOLLOWING DAY. AT THE TIME OF TROUBLESHOOTING, THE PUMP WAS NOT AVAILABLE FOR REVIEW. THE PATIENT'S FATHER REPORTED THAT HE HAS NOT NOTICED ANY WETNESS IN THE CARTRIDGE COMPARTMENT AND HAS NOT NOTED ANY LEAKS FROM THE CARTRIDGE. THE REPORTER CONFIRMED THE PATIENT CHANGES SITE EVERY OTHER DAY, DENIES ANY PROBLEMS WITH KINKED SITES, DENIED ANY ISSUE WITH INSERTION AND CONFIRMED THERE WERE NO AIR BUBBLES.

    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 B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| L| R