BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2125339 · Received June 15, 2011

    Report

    Report Number
    2531779-2011-04184
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL # 2531779-02/25/11-001-R. DEVICE EVALUATION: A CARTRIDGE OF THE SAME LOT NUMBER WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/07/2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. THERE WAS NO DEFECT FOUND ON INVESTIGATION. 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 PATIENT REPORTED EXPERIENCING BLOOD GLUCOSE (BG) BETWEEN 250 MG/DL AND 400 MG/DL FOR THE PAST TWO TO THREE WEEKS. THERE WERE NO REPORTED SYMPTOMS OR KETONES. HE STATED THAT HE WAS USING CARTRIDGES WITH LOT NUMBER B201581, WHICH WERE INCLUDED IN THE CARTRIDGE RECALL. THE PATIENT CONFIRMED THAT HE HAD NOT NOTICED ANY LEAKING, BUT SUSPECTED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE CARTRIDGES, AFFECTING HIS BG. THE REPORTED BG VALUES DO NOT MEET CRITERIA FOR REPORTABILITY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION CARTRIDGES FROM LOT # B201581 MAY HAVE MALFUNCTIONED WHILE IN USE BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR