BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042180 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02003
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. THE RETAINED FROM CARTRIDGES WITH THE REPORTED LOT # WERE CONFIRMED TO BE DEFECTIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE RPTR CLAIMED THAT SHE HAS THE RECALL CARTRIDGE WITH LOT # B201803 AND B201582. DURING THE USAGE OF THE REPORTED LOT NUMBER, THE RPTR CLAIMED THAT THE PT HAD HIGH BLOOD GLUCOSE OF "400 MG/DL" WITH KETONES DETECTED. THE LOT # B201582 REPORTEDLY WAS LEAKING THE DAY PRIOR TO THE CALL TO ANIMAS. THERE WAS NO LEAKAGE REPORTED ON THE LOT # B201803. DURING TROUBLESHOOTING, THE RPTR STATED SHE DISCARD THE EFFECTED CARTRIDGE AND WILL NOT BE RETURNING THE PRODUCT. THE PT HAS STARTED ON THE BACKUP PLAN FOR INSULIN TREATMENT SINCE THE ONSET OF THE LEAKAGE ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY HAD HYPERGLYCEMIA WHILE USING THE RECALL LOT # B201582.

    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 12 YR Life Threatening| R