BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2523634 · Received April 9, 2012

    Report

    Report Number
    2531779-2012-02955
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Report Date
    March 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012. DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOW # B201683 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. ALL O-RINGS WERE FOUND TO BE INTACT AND PROPERLY SEATED; THERE WERE NO MISSING O-RINGS OBSERVED. ALL RETAIN SAMPLES FROM LOT # B201863 WERE VISUALLY INSPECTED FOR MISSING O-RINGS WITH NO FAILURES FOUND. A FILL TEST AND LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. THE USER STATED THAT THE CARTRIDGE WAS THROWN AWAY. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED ANIMAS ON MARCH 12 REPORTING THAT THE PUMP ALARMED AFTER THE CARTRIDGE CAME APART. THE ALARM CODE WAS NOT SPECIFIED. SHE SAID THAT WHEN TAKING OUT THE CARTRIDGE THE CARTRIDGE CAME APART (THE PLUNGER DETACHED FROM THE REST OF THE CARTRIDGE) AND SPILLED OUT INSULIN. THE PATIENT HAS DRIED OUT THE CARTRIDGE COMPARTMENT AND REPLACED THE CARTRIDGE. AFTERWARD THE PUMP CONTINUED TO FUNCTION AS DESIRED. SHE SAID THAT THE FIRST CARTRIDGE DID NOT HAVE AN O-RING NEAR THE PLUNGER. SHE ALSO DID NOT FIND THE O-RING IN THE CARTRIDGE COMPARTMENT. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE CARTRIDGE ALLEGEDLY FELL APART DURING PUMP THERAPY.

    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 14 YR