BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4234396 · Received November 7, 2014

    Report

    Report Number
    2531779-2014-31838
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED AND RETAIN SAMPLE, B201981 WAS EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION REVEALED NO DAMAGE TO THE CARTRIDGE. A FILL TEST WAS COMPLETED WITH NO DIFFICULTIES FILLING AND NO AIR BUBBLE FORMATION INSIDE THE CARTRIDGE. THE CARTRIDGE CYCLED NORMALLY. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. THERE WAS NO LEAKAGE AT THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE ON 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 SITE/SET/CART (CARTRIDGE LEAK) ISSUE. THE WAS REPORTEDLY MOISTURE AND CORROSION IN THE CARTRIDE COMPARTMENT. 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
    719250 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201981

    Patients

    Seq Age Sex Outcome Treatment
    1