BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2040006 · Received March 25, 2011

    Report

    Report Number
    2531779-2011-01917
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    February 24, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT SMELLED INSULIN INSIDE HER PUMP FOR SEVERAL WEEKS. SHE ALSO REPORTED HER INSULIN USAGE INCREASED DURING THE SAME TIME PERIOD IN ORDER TO MAINTAIN USUAL BLOOD GLUCOSE (BG) RANGE. THE PT REPORTED THAT HER HIGHEST BG READING WAS 150 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1