BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2156438 · Received July 11, 2011

    Report

    Report Number
    2531779-2011-04814
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: 100-124-01. LOT #: B201652. THE CARTRIDGE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A CARTRIDGE WAS RETURNED TO ANIMAS FOR EVALUATION. THE CARTRIDGE WAS VISUALLY INSPECTED AND NO DAMAGE OR DEFECTS WERE NOTED. THE CARTRIDGE WAS FILLED AND NO AIR BUBBLES OR LEAKS WERE OBSERVED. THE LUER CONNECTION AND, O-RINGS WERE OBSERVED AND NO LEAKING WAS OBSERVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SMELLING INSULIN AND SEEING AIR BUBBLES IN THE CARTRIDGE SEVERAL HOURS AFTER PERFORMING A ROUTINE CARTRIDGE AND SITE/SET CHANGE. HE STATED THAT HE DID NOT EXPERIENCE ANY BLOOD GLUCOSE EXCURSIONS AS A RESULT OF THE INCIDENT. THE PATIENT REPORTED THAT THERE WAS NO VISIBLE MOISTURE INSIDE THE CARTRIDGE COMPARTMENT, AND NO EVIDENCE OF LEAKING FROM THE LUER END OF THE CARTRIDGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR