BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION CARTRIDGE

    MDR report key: 2060736 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02339
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S FATHER REPORTED THAT THERE WAS A SMELL OF INSULIN AT THE LUER LOCK BETWEEN THE INFUSION SET AND THE CARTRIDGE. THE REPORTER DENIES ANY SIGNS OF CRACKS OR LEAKING IN EITHER THE INFUSION SET OR THE CARTRIDGE AND STATES IT IS TIGHTENED SECURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP IR 1200/1250/2020/OTP B201536

    Patients

    Seq Age Sex Outcome Treatment
    1