BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2123232 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04125
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #: B201643. (B)(6). 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

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. A RETAIN CARTRIDGE SAMPLE OF THE SAME LOT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE WITH THE LAST TWO CARTRIDGE CHANGES FOR CARTRIDGE LOT NUMBER B201643. HE STATED THAT HE BELIEVED HIS TECHNIQUE FOR PRESSURIZING THE INSULIN VIAL AND FILLING THE CARTRIDGE WAS INCORRECT. THE FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) BETWEEN 100 MG/DL AND 390 MG/DL. THERE WERE NO REPORTED SYMPTOMS OR KETONES. IT WAS REPORTED THAT THE PATIENT WAS GOING THROUGH PUBERTY, AND ALSO HAD A SINUS INFECTION. THE REPORTED BG EXCURSIONS DO NOT MEET CRITERIA FOR REPORTABILITY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED PRESENCE OF 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 10 YR