BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3120392 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06700
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE CARTRIDGE HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. A FILL TEST, FORCE TEST, AND LEAK TEST WERE PERFORMED WITH NO DEFECTS FOUND DURING TESTING; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THE METER READ ¿HIGH¿ ON (B)(6) 2013. THE PATIENT REPORTEDLY HAD KETONES, WENT TO THE HOSPITAL, WAS TREATED WITH FLUIDS AND ANTIBIOTICS AND THEN RELEASED FROM THE HOSPITAL AFTER THE PATIENT¿S BLOOD GLUCOSE (BG) WAS REPORTED TO BE 200 MG/DL. THERE WAS REPORTEDLY LEAKING NOTED IN THE CARTRIDGE COMPARTMENT. THE REPORTER STATED THAT SHE DID NOT KNOW WHY THE LEAKING HAD OCCURRED OR WHY THE TUBING WAS PULLED OFF AT THE LUER CONNECTION OF THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE LEAKING ISSUE AT THE LUER LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222141 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| L| R