BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2043547 · Received March 24, 2011

    Report

    Report Number
    2531779-2011-01939
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Report Date
    February 23, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPORTER REPORTED THE INSULIN CARTRIDGE WAS LEAKING AND THE PUMP CARTRIDGE COMPARTMENT WAS WET. THE PT OBTAINED BLOOD GLUCOSE READINGS 'GREATER THAN 300 MG/DL'. THE PT DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PT DID NOT SEEK ANY MEDICAL ATTENTION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    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