BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2043552 · Received March 24, 2011

    Report

    Report Number
    2531779-2011-01929
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201581 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, THE PT'S MOTHER, REPORTED THE PT OBTAINED BLOOD GLUCOSE READINGS RANGING FROM 200 MG/DL TO 400 MG/DL, AND OBSERVED AIR BUBBLES IN THE CARTRIDGE. THE PT'S HCP ADJUSTED HER INSULIN DOSES DUE TO THE BLOOD GLUCOSE READINGS. THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. NO ADVERSE EVENT WAS 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. IR1200/1250/2020/OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1