BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2070491 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02011
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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
    AZ, 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. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201575 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FORM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT REPORTED THAT CARTRIDGES OUT OF HIS SUPPLIES LEAKED WHEN HE FILLED THE CARTRIDGES WITH INSULIN AND WERE NOT USED. THE PT STATED THAT ON (B)(6) 2011, HE FILLED ANOTHER CARTRIDGE AND IT DID NOT LEAK DURING THAT TIME; LATER, HE DID NOT NOTICE ANY MOISTURE IN THE CARTRIDGE COMPARTMENT. HE REPORTED THAT WHILE USING THIS CARTRIDGE HIS BLOOD GLUCOSE WAS 420MG/DL WITHOUT KETONES OR SYMPTOMS OF HYPERGLYCEMIA. THE PT DENIED THE PRESENCE OF AIR BUBBLES, REDNESS AT THE INFUSION SITE, OR BENT OR KINKED CANNULAS. HE SAID, HE REPLACED THE INFUSION SET AND CARTRIDGE; HIS BLOOD GLUCOSE RESOLVED INTO HIS USUAL RANGE. THE PT DECLINED OFFERS FROM CUSTOMER SUPPORT TO TROUBLE SHOOT THE PUMP AS HE NOTED THAT HIS BLOOD GLUCOSE READINGS HAVE BEEN WITHIN TARGET SINCE THAT TIME.

    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 B201575

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR