BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3882497 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17542
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO DEVICE HAS BEEN RETURNED FOR EVALUATION, A RETAINED SAMPLE WAS PULLED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE CYCLED NORMALLY AND SUCCESSFULLY FILLED WITH NO AIR BUBBLES FORMED INSIDE THE CARTRIDGE. A CARTRIDGE LEAK TEST WAS PERFORMED AND NO LEAKS WERE OBSERVED FROM ANYWHERE ON THE CARTRIDGE. A CARTRIDGE FORCE TEST WAS COMPLETED AND THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS.

    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 FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING MULTIPLE LOSS OF PRIME WARNINGS ON THE CURRENT CARTRIDGE; THE REPORTER CONFIRMED THAT THE CARTRIDGE HAD NOT BEEN CHANGED SINCE THE ISSUE BEGAN. 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
    357571 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION C200003

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR