BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033418 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01869
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 22, 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
    VA, 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.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THAT FROM (B)(6), 2011 THE PT OBSERVED AIR BUBBLES IN THE 'BACK END' OF THE INSULIN CARTRIDGE, AND SHE OBTAINED ELEVATED BLOOD GLUCOSE READINGS RANGING FROM 250 MG/DL TO 365 MG/DL. THE PT DID NOT OBSERVE ANY LEAKS FROM THE CARTRIDGE. DURING THIS TIME PERIOD THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND SHE 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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR