BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2012904 · Received March 2, 2011

    Report

    Report Number
    2531779-2011-01128
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS RETURNED TO ANIMAS. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED AND FLUID WAS OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE PT REPORTED BLOOD GLUCOSE AT 571 MG/DL WITH EXTREME THIRST AND EMESIS. SHE REPORTED THAT SHE DELIVERED A 20 UNIT CORRECTION BOLUS AND HER BLOOD GLUCOSE DECREASED TO 364 MG/DL. THE PT STATED THAT SHE REMOVED THE CARTRIDGE AND DISCOVERED INSULIN IN THE CARTRIDGE COMPARTMENT. SHE SAID THAT THE LURE LOCK WAS SECURE; THE LEAK APPEARED TO BE AT THE BOTTOM OF THE CARTRIDGE. THE PT STATED THAT SHE USED ABOUT FOUR CARTRIDGES FROM THE SAME BOX WITHOUT ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention