BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033444 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01874
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 REPORTED THAT HE MAY HAVE DISCOVERED THAT INSULIN LEAKED OUT OF ONE OF HIS CARTRIDGES. HE THINKS IT MAY HAVE LEAKED BECAUSE HE COULD SMELL THE INSULIN AND THE CARTRIDGE COMPARTMENT MAY HAVE BEEN DAMP. HE SAYS HE DID NOT EXPERIENCE CHANGES TO BLOOD GLUCOSE LEVELS DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR