BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2636647 · Received July 2, 2012

    Report

    Report Number
    2531779-2012-05960
    Event Type
    Injury
    Date Received
    July 2, 2012
    Report Date
    June 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 SUBMITTED (B)(4) 2012. DEVICE EVALUATION: NO PRODUCT WAS RETURNED. A RESERVED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER # B201760 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND. 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

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) AS HIGH AS 500MG/DL TO 600MG/DL FOR ABOUT TWO DAYS. THE PATIENT DENIED SYMPTOMS OF HYPERGLYCEMIA BUT REPORTED MILD KETONES. THE PATIENT ALLEGED THAT THE BLACK O-RINGS INSIDE THE CARTRIDGE APPEARED TO BE BOWED OR CURVED INTO U-SHAPES. HE REPORTED THAT THE CARTRIDGE COMPARTMENT WAS FULL OF INSULIN. THE PATIENT REPORTED THAT HE CHANGED THE CARTRIDGE AND THE BG SLOWLY CAME BACK DOWN TO TARGET. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION THAT A CARTRIDGE DEFECT CAUSED INSULIN TO LEAK OUT OF THE CARTRIDGE, AND THAT SERIOUS HYPERGLYCEMIA WAS THE END RESULT.

    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 16 YR Life Threatening