BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3771870 · Received April 24, 2014

    Report

    Report Number
    2531779-2014-11313
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 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

    (B)(4). THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS AS FOLLOWS: A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING THE CARTRIDGE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    A RETAINED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK, FORCE, AND FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. 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 A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER STATED THAT A LOSS OF PRIME WARNING HAD OCCURRED 3 OR MORE TIMES. REPORTEDLY, THERE WAS NO CHANGE IN FORCE OR TEMPERATURE. 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
    249796 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B202053

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR