BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2433221 · Received January 31, 2012

    Report

    Report Number
    2531779-2012-00765
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2012
    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: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201692 WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. A FORCE TEST WAS PERFORMED WITH NO FAILURES NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES NOTED INSIDE 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

    THE REPORTER STATED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE VALUE OF 30 MMOL/L WITH NAUSEA AND VOMITING. THE REPORTER STATED THAT WHEN THE SITE, SET, AND CARTRIDGE WERE CHANGED, AIR BUBBLES WERE NOTED IN THE CARTRIDGE. TROUBLESHOOTING INDICATED THAT THE REPORTER WAS USING REFRIGERATED INSULIN TO FILL THE CARTRIDGE. CUSTOMER SUPPORT ADVISED THE REPORTER THAT TROUBLESHOOTING FOUND NO PRODUCT DEFECTS; CUSTOMER SUPPORT ADVISED THE REPORTER TO USE ONLY ROOM TEMPERATURE INSULIN IN THE CARTRIDGE TO AVOID AIR BUBBLES IN THE FUTURE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 6 YR Required Intervention