BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2588846 · Received May 25, 2012

    Report

    Report Number
    2531779-2012-04545
    Event Type
    Injury
    Date Received
    May 25, 2012
    Report Date
    April 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201732 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, FORCE TEST, AND FILL 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

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE CARTRIDGE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. THE CARTRIDGE PASSED VISUAL EXAMINATION, FILL, FORCE, AND LEAK TESTING.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012, REPORTING THAT THE PATIENT HAD ELEVATED BLOOD GLUCOSE WITH SYMPTOMS OF INCREASED, THIRST, HUNGER, AND URINATION AND FATIGUE. THE REPORTER STATED THAT THE CARTRIDGE WAS ENDING UP WITH AIR BUBBLES WHICH WAS CONTRIBUTING TO THE PATIENT'S BLOOD GLUCOSE LEVELS. THE REPORTER ALSO STATED THAT THE PATIENT WAS TAKING MEDICATIONS THAT MAY HAVE CONTRIBUTED AS THE PATIENT'S BLOOD GLUCOSE "GOES CRAZY" WITH THE MEDICATION. THE REPORTER CONFIRMED USING ONLY ROOM TEMPERATURE INSULIN AND USING CORRECT CARTRIDGE FILLING TECHNIQUES BUT AIR BUBBLES CONTINUED. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA CONTRIBUTED TO BY AIR BUBBLES IN THE CARTRIDGE.

    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 15 YR Life Threatening