BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2312320 · Received October 28, 2011

    Report

    Report Number
    2531779-2011-08025
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201633 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. A LEAK TEST AND A FILL TEST WERE 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011 HE EXPERIENCED BLOOD GLUCOSE (BG) OF 24 MMOL/L, AND HIS BG REMAINED ELEVATED OVER (B)(6). THE PATIENT STATED THAT HE DID NOT CHANGE OUT HIS SUPPLIES UNTIL (B)(6) 2011, AND NOTED DAMPNESS WHEN CHANGING SUPPLIES. THE PATIENT REPORTEDLY WAS UNABLE TO KEEP FLUIDS DOWN AND WAS VOMITING BLOOD, AND WENT TO THE HOSPITAL ON (B)(6) 2011 WITH BG OF 24.5 MMOL/L. THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS; THE PATIENT STATED THAT HE AGAIN NOTED MOISTURE AT THE CONNECTION BETWEEN THE TUBING AND THE CARTRIDGE. THE PATIENT WAS REPORTEDLY REMOVED FROM THE PUMP AND TREATED WITH INTRAVENOUS INSULIN WHILE IN THE HOSPITAL. THE USER GUIDE INSTRUCTS THE USER TO CHANGE SUPPLIES WITH BG ELEVATIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO A LEAKY CARTRIDGE/TUBING ISSUE.

    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 22 YR