BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3355434 · Received September 18, 2013

    Report

    Report Number
    2531779-2013-15650
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Report Date
    August 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE CARTRIDGE 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.

    Additional Manufacturer Narrative · 1

    NO FAILURES WERE OBSERVED DURING THE INCOMING INSPECTION. THE CARTRIDGES WERE STERILIZED WITH NO ISSUES AND PASSED BACTERIAL ENDOTOXIN TESTING AND STERILITY TESTING WITH NO ISSUES. THE CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED TO THE LUER CONNECTION OR O-RINGS. A ¿FILL¿ TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND WITH FILLING THE CARTRIDGE. A FORCE TEST WAS COMPLETED AND FOUND TO BE WITHIN SPECIFICATIONS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT THE INSULIN WAS ¿MAKING A LOT OF FOAM¿ IN CARTRIDGES FROM LOT #B201979. THE DISTRIBUTOR STATED THAT THE ISSUE IS PRESENT ONLY IN CARTRIDGES FROM THIS LOT; CARTRIDGES FROM OTHER LOTS HAVE BEEN TRIED AND THE INSULIN DOES NOT MAKE FOAM IN THEM. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470024 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1