BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4121768 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27649
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON 10/07/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE RETAINED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/31/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A CARTRIDGE LEAK. THE REPORTER STATED THAT EVERY CARTRIDGE FOR APPROXIMATELY THREE MONTHS HAS BEEN LEAKING. THE PATIENT HAD TRIED CARTRIDGES FROM SEVERAL BOXES. THE BOXES ARE STORED AT ROOM TEMPERATURE, THE CARTRIDGES ARE NOT REUSED, THEY ARE CYCLED CORRECTLY, AND NOT OVERFILLED. THE REPORTER STATED THAT THERE IS NO OBVIOUS DAMAGE TO CARTRIDGE AND NO LEAKING PRIOR TO USE. WHEN PATIENT REMOVED THE CARTRIDGE THEY WERE ABLE TO POUR ABOUT 1/2 TEASPOON OF INSULIN FROM THE PUMP EVERY TIME THEY CHANGE THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601510 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION C200007

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR