BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2752542 · Received September 20, 2012

    Report

    Report Number
    2531779-2012-10932
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 24, 2012
    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

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201746 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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

    THE CARTRIDGES HAVE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE CURRENT BOX OF CARTRIDGES SHE IS USING HAVE ALL LEAKED FROM THE PLUNGER END OF THE CARTRIDGE SINCE THE BOX WAS OPENED FOR US. THE PATIENT STATED THAT 5 CARTRIDGES FROM THE SAME BOX HAVE BEEN USED, AND ALL HAVE LEAKED FROM THE PLUNGER END. THE PATIENT DENIED ANY DAMAGE TO THE CARTRIDGES. THE PATIENT NOTED THAT THE CURRENT CARTRIDGE SHE HAD IN THE PUMP WAS NOT LEAKING. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED CARTRIDGE ISSUE REMAINED UNRESOLVED AND BECAUSE A LEAKING CARTRIDGE CAN LEAD TO UNDER-DELIVERY OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201746

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR