BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3037543 · Received April 5, 2013

    Report

    Report Number
    2531779-2013-03675
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    March 11, 2013
    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

    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

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201799; A LEAK TEST WAS PERFORMED WITH NO FAILURES; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ELSEWHERE ON THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT MULTIPLE CARTRIDGES HAVE LEAKING INSIDE THE CARTRIDGE COMPARTMENT RESULTING IN THE PATIENT EXPERIENCING BLOOD GLUCOSE (BG) OF 350MG/DL WITH HEADACHE AND BLURRED VISION. A SPECIFIC DATE FOR THE BG EXCURSION(S) WAS NOT PROVIDED. THE REPORTER STATED THIS ISSUE HAS OCCURRED WITH TWO DIFFERENT CARTRIDGE LOTS. THE PATIENT HAS REPORTEDLY DISCONTINUED INSULIN PUMP THERAPY AND IS ON A BACK-UP PLAN FOR INSULIN DELIVERY. THE REPORTER NOTED THAT THE LUER LOCK ON THE CARTRIDGE IS TIGHT AND SHE CANNOT DETERMINE WHERE ON THE CARTRIDGE THE INSULIN IS LEAKING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY DUE TO A LEAKING CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141803 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening