BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2064177 · Received April 4, 2011

    Report

    Report Number
    2531779-2011-02098
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Report Date
    February 27, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201583 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 PT OBTAINED ELEVATED BLOOD GLUCOSE READINGS FOR (B)(6), RANGING FROM 200 MG/DL TO 484 MG/DL. DURING THIS TIME PERIOD, THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DID NOT SEEK ANY MEDICAL ATTENTION. THE PT¿S WIFE NOTED A LEAK AT THE PLUNGER END OF THE INSULIN CARTRIDGE. THE PT REPORTED THERE WERE NO BENT OR KINKED CANNULAS OR INFUSION SITE ISSUES. 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 B201583

    Patients

    Seq Age Sex Outcome Treatment
    1