BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2045955 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02252
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. RETAIN 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 REPORTER CLAIMED THAT THE PT'S BLOOD GLUCOSE WAS ELEVATED TO 470 MG/DL FROM (B)(6) 2011 WHILE USING THE RECALL CARTRIDGE LOT #201581. THE PT HAD SYMPTOMS DESCRIBED AS "NAUSEA AND MODERATE KETONES." HER BLOOD GLUCOSE WAS CORRECTED WITH BOTH THE INSULIN PUMP AND SYRINGE. THE PT BLOOD GLUCOSE IS CURRENTLY WITHIN THE 100 RANGE. DURING TROUBLESHOOTING, THE REPORTER NOTED THAT SHE NOTICED LEAKAGE ON THE SUBJECT CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY HAD HYPERGLYCEMIC SYMPTOMS AND READINGS WHILE USING THE CARTRIDGE WITH THE RECALL LOT#201581.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020/ OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R