BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2851708 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14094
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK TEST WAS PERFORMED WITH NO FAILURES. 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING 2 CARTRIDGES DEVELOPED AIR BUBBLES AFER CYCLING THE CARTRIDGE PROPERLY. AT THE TIME OF THE CALL, THE REPORTER INFORMED CUSTOMER SUPPORT THAT SHE HAD DISCARDED THE SUBJECT CARTRIDGES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201869

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR