BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4090910 · Received September 15, 2014

    Report

    Report Number
    2531779-2014-26327
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. NO DEFECT WAS FOUND. A VISUAL INSPECTION, A FORCE TEST AND A FILL TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. 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. A LOT REVIEW WAS PERFORMED AND NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION. THE CORRECT LOT NUMBER FOR THE CARTRIDGE ASSOCIATED WITH THIS CASE IS D200071. THE DEVICE ANALYSIS RESULTS ARE FOR LOT # D200071.

    Description of Event or Problem · 1

    ON (B(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (SITE/SET/CART ISSUE) ISSUE. 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
    568462 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B200071

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR