BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2073101 · Received April 13, 2011

    Report

    Report Number
    2531779-2011-02757
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 27, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201582 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THERE WAS A FAINT ODOR OF INSULIN INSIDE THE CARTRIDGE COMPARTMENT; SHE SAID THAT THE SMELL INDICATED A PROBABLE INSULIN LEAK DURING THE TIME WHEN SHE USED THE CARTRIDGES FROM LOT # B201582. THERE WAS NO EVIDENCE OF MOISTURE AT THE TIME OF THE CONTACT AND BLOOD GLUCOSE WAS WELL CONTROLLED SINCE SWITCHING TO A NEW SUPPLY OF CARTRIDGES. THE PT REPORTED THAT SHE HAD INTERMITTENT ELEVATED BLOOD GLUCOSE (<375 MG/DL) DURING THE TIME SHE USED THE COMPLAINANT CARTRIDGES. SHE DENIED SYMPTOMS OF HYPERGLYCEMIA OR THE PRESENCE OF KETONES AT ANY TIME. THIS COMPLAINT IS BEING REPORTED DUE TO A PROBABLE LEAKAGE OF INSULIN FROM A CARTRIDGE.

    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 B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR